Public Notifications of the Service Requests

FINPEDMED / NORDICPEDMED aim to increase public awareness about the pediatric drug / medical device development and pediatric clinical trials in Finland and in other Nordic Countries. This can be promoted by publishing some basic information of the Service Requests submitted to FINPEDMED / NORDICPEDMED. Service Requests are preliminary inquiries of possible new trials OR proposed expert consultations, both addressed for the clinical trial feasibility evaluation, or for the medical / scientific assessment.

Service Request´s public information is listed on a table below. You may open each request and look for the details by clicking the bar arrow beside the number. Service Request category C includes Consultations and category R includes Basic feasibility assessment for a new clinical trial.

# R3561-205 SMA type 2 and type 3a (treatment naive)
Service Request status Completed
2. Medical condition or disease SMA type 2 and type 3a (treatment naive)
10. Start date Q1 2022
11. Completion date Q2 2026
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-61 Metachromatic leukodystrophy (MLD)
Service Request status Completed
2. Medical condition or disease Metachromatic leukodystrophy (MLD)
# R3561-204 Hypereosinophilic syndrome
Service Request status Completed
2. Medical condition or disease hypereosinophilic syndrome
10. Start date Q3 2021
11. Completion date 2023
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-203 Neurofibromatosis Type 1 and Plexiform Neurofibromas
Service Request status Completed
2. Medical condition or disease Neurofibromatosis Type 1 and Plexiform Neurofibromas
10. Start date Not known
11. Completion date Not known
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-202 Hemophilia
Service Request status Completed
2. Medical condition or disease Hemophilia
10. Start date Jan 2021
11. Completion date Jun 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-201 Pruritis in adolescents on haemodialysis
Service Request status Completed
2. Medical condition or disease Pruritis in adolescents on haemodialysis
10. Start date Unnown -
11. Completion date Unknown
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-60 NASH
Service Request status Completed
2. Medical condition or disease NASH
# R3561-200 Migraine
Service Request status Completed
2. Medical condition or disease Migraine
10. Start date Q1, 2022
11. Completion date Not known
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-198 Peanut allergy
Service Request status Completed
2. Medical condition or disease Peanut allergy
10. Start date FPFV June 2021
11. Completion date LPFV September 2022, LPLV February 2024
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-59 Cyanotic congenital heart disease (CHD)
Service Request status Completed
2. Medical condition or disease cyanotic congenital heart disease (CHD)
# C3561-58 Obesity
Service Request status Completed
2. Medical condition or disease Obesity
# R3561-197 Neonatal critical care
Service Request status Completed
2. Medical condition or disease neonatal critical care
10. Start date Q4 2020
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-57 Chronic kidney disease
Service Request status Completed
2. Medical condition or disease Chronic kidney disease
# R3561-196 Asthma
Service Request status Completed
2. Medical condition or disease Asthma
10. Start date FPFV December 2020
11. Completion date LPLV January 2022
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-195 MS-disease
Service Request status Completed
2. Medical condition or disease MS-disease
10. Start date FPFV may 2021
11. Completion date LPLT Jun 2026
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-194 Juvenile PsA
Service Request status Completed
2. Medical condition or disease Juvenile PsA
10. Start date N/A
11. Completion date N/A
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-193 Atopic Dermatitis
Service Request status Completed
2. Medical condition or disease Atopic Dermatitis
10. Start date Oct 2020
11. Completion date Apr 2023
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-192 Familial hypercholesterolemia
Service Request status Completed
2. Medical condition or disease Familial hypercholesterolemia
10. Start date End of 2020
11. Completion date LPLV Q2 2023
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-55 Pediatric ALL
Service Request status Completed
2. Medical condition or disease Pediatric ALL
# R3561-188 Pulmonary arterial hypertension
Service Request status Completed
2. Medical condition or disease pulmonary arterial hypertension
10. Start date ASAP
11. Completion date October 2027
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-187 Duschenne Muscular Dystrophy (DMD)
Service Request status Completed
2. Medical condition or disease Duschenne Muscular Dystrophy (DMD)
10. Start date 2020
11. Completion date 144 weeks
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-186 Spinal Muscular Atrophy
Service Request status Completed
2. Medical condition or disease Spinal Muscular Atrophy
10. Start date 01Jan2020
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-185 Spinal Muscular Atrophy
Service Request status Completed
2. Medical condition or disease Spinal Muscular Atrophy
10. Start date 01Jan2020
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-184 ILD
Service Request status Completed
2. Medical condition or disease ILD
10. Start date 30Sep2019
11. Completion date 25Feb2022
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-183 DMD patients with deletion amenable to Exon 51skipping
Service Request status Completed
2. Medical condition or disease DMD patients with deletion amenable to Exon 51skipping
10. Start date 28Jun 2019
11. Completion date Aug 2024
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-181 Episodic and/or Chronic Migraine
Service Request status Completed
2. Medical condition or disease Episodic and/or Chronic Migraine
10. Start date Q3-2019
11. Completion date Q2-2023
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-180 Mucopolysaccharidoses (MPS), type IV
Service Request status Completed
2. Medical condition or disease Mucopolysaccharidoses (MPS), type IV
10. Start date N/A
11. Completion date N/A
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-176 Hypoparathyroidism
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Hypoparathyroidism
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
e. Adolescents 12-17 years (under 18 years)
10. Start date Autumn 2019
11. Completion date Not known
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-175 Influenza
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease Influenza
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
10. Start date Flu season 2019/2010
11. Completion date Flu season 2019/2010
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-54 Psoriasis
Service Request status Completed
2. Medical condition or disease Psoriasis
# R3561-174 Epilepsy
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease Epilepsy
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Estimated Date Oct 2019 for Nordic Countries
11. Completion date Last patient In (05May2020)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-173 CML and other leukemias, lymphoma, solid tumors
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Oncology
2. Medical condition or disease CML and other leukemias, lymphoma, solid tumors
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date June 2019
11. Completion date NK
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-172 Duchenne Muscular Dystrophy
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease Duchenne Muscular Dystrophy
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Ongoing since 2016
11. Completion date May 23
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-171 Retinopathy of prematurity
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neonatology
Ophthalmology
2. Medical condition or disease Retinopathy of prematurity
8. Patients / study subjects: Age group / groups a. Preterm newborn infants (gestational age <37 weeks)
10. Start date Jul2019 / FPFV (20090)
11. Completion date Jan2021 / LPLV (20090)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-170 Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Mellitus
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Mellitus
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date March 2019
11. Completion date March 2026
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-168 New onset T1DM
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease New onset T1DM
8. Patients / study subjects: Age group / groups N/A
10. Start date N/A
11. Completion date N/A
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-53 Schizophrenia
Service Request status Completed
2. Medical condition or disease schizophrenia
# R3561-165 Venous thromboembolic event
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
Haematology
Oncology
Surgery
Other – not classified
2. Medical condition or disease Venous thromboembolic event
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Study is ongoing globally
11. Completion date April 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-52 AGU
Service Request status Completed
2. Medical condition or disease AGU
# C3561-51 AGU patients
Service Request status Completed
2. Medical condition or disease AGU patients
# R3561-162 Heterozygous Familial Hypercholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Heterozygous Familial Hypercholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date April 2018
11. Completion date Mar 2022
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-160 SMA (Spinal Muscular Atrophy) TYPE 2 and TYPE 3
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease SMA (Spinal Muscular Atrophy) TYPE 2 and TYPE 3
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date FPFV JUNE 2018
11. Completion date LPLV APR 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-50 Type 1 spinal muscular atrophy
Service Request status Completed
2. Medical condition or disease Type 1 spinal muscular atrophy
# R3561-159 Homozygous familial hypersholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Homozygous familial hypersholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date May 2018
11. Completion date June 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-157 Type 2 diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type 2 diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date 19Apr2017
11. Completion date 31Dec2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-49 Heterozygous familial hypercholesterolemia (children and adolescents)
Service Request status Completed
2. Medical condition or disease heterozygous familial hypercholesterolemia (children and adolescents)
# C3561-48 Severe ulcerative colitis (US) or Crohn’s disease (CD).
Service Request status Completed
2. Medical condition or disease severe ulcerative colitis (US) or Crohn’s disease (CD).
# C3561-47 Cystic Fibrosis
Service Request status Completed
2. Medical condition or disease Cystic Fibrosis
# R3561-156 Pediatric Atopic Dermatitis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Allergology
Dermatology
Immunology
2. Medical condition or disease Pediatric Atopic Dermatitis
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Part A: Dec 2016 Part B: Dec 2016
11. Completion date Part A: Mar 2018 Part B: Mar 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-155 Type II Diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type II Diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date 01Mar2017
11. Completion date 31Jan2022
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-154 Respiratory Syncytial Virus
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease Respiratory Syncytial Virus
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
10. Start date Oct2016
11. Completion date Jul2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-153 Psoriatic and enthesitis-related arthritis JIA subtypes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Rheumatology
2. Medical condition or disease Psoriatic and enthesitis-related arthritis JIA subtypes
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date March 2017
11. Completion date November 2020
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-46 Cystic Fibrosis
Service Request status Completed
2. Medical condition or disease Cystic Fibrosis
# R3561-152 Pulmonary Arterial Hypertension (PAH)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Pulmonary Arterial Hypertension (PAH)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 2016
11. Completion date 2020
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-151 Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Dermatology
Infectious diseases
2. Medical condition or disease Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
10. Start date 01/2017
11. Completion date 02/2019
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-150 Glucocorticoid induced Osteoporisis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Other – not classified
2. Medical condition or disease Glucocorticoid induced Osteoporisis
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Dec 2016
11. Completion date Dec 2021 (enrolment ending: Dec 2018)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-149 Recurrent pediatric clostridium difficile infections
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease recurrent pediatric clostridium difficile infections
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date TBD
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-148 Type 2 diabetes mellitus 10 -17 years old
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type 2 diabetes mellitus 10 -17 years old
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date Estimation: Study to be started 2-3 Q2016
11. Completion date Estimation 2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-147 Venous thromboembolism
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease venous thromboembolism
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q2 2016
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-45 Prohlylaxis of thrombotic complications in children born with a single ventricle
Service Request status Completed
2. Medical condition or disease prohlylaxis of thrombotic complications in children born with a single ventricle
# C3561-44 Crohn´s disease
Service Request status Completed
2. Medical condition or disease Crohn´s disease
# R3561-146 Major Depressive Disorder (MDD)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Adolescent Psychiatry
Child Psychiatry
2. Medical condition or disease Major Depressive Disorder (MDD)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date FPI 01Mar2016 (screened)
11. Completion date Enrolment 28 months
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-43 Juvenile idiopathic arthritis
Service Request status Completed
2. Medical condition or disease Juvenile idiopathic arthritis
# R3561-143 Secondary thrombocytopenia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Oncology
2. Medical condition or disease secondary thrombocytopenia
8. Patients / study subjects: Age group / groups N/A
10. Start date 2015
11. Completion date 2019
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-42 MDD (major depression disorder)
Service Request status Completed
2. Medical condition or disease MDD (major depression disorder)
# R3561-142 Persistent asthma on ICS/LABA treatment
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Allergology
2. Medical condition or disease Persistent asthma on ICS/LABA treatment
8. Patients / study subjects: Age group / groups N/A
10. Start date 5 / 2016
11. Completion date Last patient last visit 1 / 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-141 Diebetes Mellitus type 1
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Diebetes Mellitus type 1
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q3 2015 (FPI)
11. Completion date Q3 2017 (LPLV)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-140 Intravascular Procedures For Congenital Heart Disease
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
Surgery
2. Medical condition or disease Intravascular Procedures For Congenital Heart Disease
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date not known at this stage
11. Completion date not known at this stage
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-41 Children with persistent asthma
Service Request status Completed
2. Medical condition or disease Children with persistent asthma
# C3561-40 Paediatric Melanoma / Lymphoma
Service Request status Completed
2. Medical condition or disease Paediatric Melanoma / Lymphoma
# R3561-139 Repeated seizures
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neonatology
Neurology
2. Medical condition or disease Repeated seizures
8. Patients / study subjects: Age group / groups a. Preterm newborn infants (gestational age <37 weeks)
b. Term newborn infants; 0-27 days
10. Start date tbc
11. Completion date tbc
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-39 Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis
Service Request status Completed
2. Medical condition or disease Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis
# R3561-138 Pediatric Treatment of VTE with rivaroxaban
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease Pediatric Treatment of VTE with rivaroxaban
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Nov 2014
11. Completion date Nov 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-137 Pediatric Treatment of VTE with rivaroxaban
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease Pediatric Treatment of VTE with rivaroxaban
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Jan 2015
11. Completion date Mar 2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-37 Type 1 Diabetes Mellitus
Service Request status Completed
2. Medical condition or disease Type 1 Diabetes Mellitus
# R3561-136 MDD
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Adolescent Psychiatry
Child Psychiatry
2. Medical condition or disease MDD
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Jan-2016
11. Completion date na
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-133 Atopic Dermatitis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Dermatology
2. Medical condition or disease Atopic Dermatitis
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q1-2015
11. Completion date Q3-2016
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-132 Heterozygous Familiar Hypercholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Heterozygous Familiar Hypercholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 6/2015
11. Completion date 9/2016
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-131 Neutropenia or expected neutropenia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Infectious diseases
Oncology
Paediatric Intensive Care
Transplantation
2. Medical condition or disease neutropenia or expected neutropenia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 24-Jun-2015 First subject entered
11. Completion date 26-Apr-2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-130 Prevention of Chemotherapy-Induced Nausea and Vomiting
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Oncology
2. Medical condition or disease Prevention of Chemotherapy-Induced Nausea and Vomiting
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date May-2015
11. Completion date June-2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-36
Service Request status Completed
# C3561-35
Service Request status Completed
# C3561-34
Service Request status Completed
# R3561-129 Euvolemic or hypervolemic hyponatremia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Other – not classified
2. Medical condition or disease euvolemic or hypervolemic hyponatremia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 18th August (first patient in US), December 2014 in Finland
11. Completion date 31rst March 2017 (last patient last visit)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-127 B-precursor ALL
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease B-precursor ALL
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Feb2015
11. Completion date Feb2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-126 Pediatric type 2 diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease pediatric type 2 diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date already started
11. Completion date Aug-2015
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-33
Service Request status Completed
# R3561-125 Epilepsy
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease Epilepsy
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date November 2014
11. Completion date November 2014
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-113 Opioid induced constipation
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Oncology
2. Medical condition or disease Opioid induced constipation
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Spring 2014
11. Completion date depending on the use of opioids
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A