Clinical trials: Pediatric Population
Major Depressive Disorder
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
- Trial name
- VLZ-MD-22 (NCT02372799)
- Testing
- Vilazodone, Fluoxetine
- Where
- 60 sites in United States, Canada
- Volunteers
- 473 people
- Sponsor
- Forest Laboratories
Diabetes Mellitus, Type 2
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or…
- Trial name
- NCT03199053
- Testing
- Dapagliflozin, Saxagliptin
- Where
- 122 sites in United States, Argentina and 21 more
- Volunteers
- 256 people
- Sponsor
- AstraZeneca
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multiple Sclerosis, Relapsing-Remitting
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS.
- Trial name
- NCT03870763
- Testing
- Dimethyl Fumarate, Peginterferon Beta-1a
- Where
- 23 sites in United States, Colombia and 11 more
- Volunteers
- 11 people
- Sponsor
- Biogen
Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.
- Trial name
- NCT05652205
- Testing
- Linaclotide
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 123 people
- Sponsor
- AbbVie
Glaucoma, Ocular Hypertension
Long-Term Non-Interventional Latanoprost Study
This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin…
- Trial name
- LYNX (NCT01265719)
- Testing
- No intervention other than routine medical care
- Where
- 29 sites in Belgium, Colombia and 12 more
- Volunteers
- 175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Influenza, Human
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine…
- Trial name
- NCT02545543
- Testing
- Seqirus QIV, Comparator QIV
- Where
- 32 sites in United States
- Volunteers
- 2,278 people, healthy volunteers welcome
- Sponsor
- Seqirus
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Glioblastoma
Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma.
- Trial name
- INTELLANCE-2 (NCT02343406)
- Testing
- Depatuxizumab mafodotin, Temozolomide, Lomustine
- Where
- 102 sites in United States, Australia and 19 more
- Volunteers
- 266 people
- Sponsor
- AbbVie
Pulmonary Arterial Hypertension
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
- Trial name
- NCT01484431
- Testing
- Tadalafil- Tablet or Oral suspension
- Where
- 16 sites in United States, Canada and 4 more
- Volunteers
- 20 people
- Sponsor
- Eli Lilly and Company
Type 2 Diabetes Mellitus
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
- Trial name
- NCT01525238
- Testing
- Dapagliflozin
- Where
- 17 sites in United States, Mexico
- Volunteers
- 53 people
- Sponsor
- AstraZeneca
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine…
- Trial name
- NCT03632720
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine, Meningococcal group B vaccine, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
- Where
- 13 sites in United Kingdom
- Volunteers
- 788 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Transfusional Iron Overload, Beta-Thalassemia
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the…
- Trial name
- NCT01363908
- Testing
- SPD602
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Shire
Hypertension
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
- Trial name
- NCT00756938
- Testing
- losartan potassium
- Volunteers
- 101 people
- Sponsor
- Organon and Co
Oesophagitis, Eosinophilic
Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
- Trial name
- NCT00358449
- Testing
- mepolizumab
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 84 people
- Sponsor
- GlaxoSmithKline
Seasonal Allergic Rhinitis (SAR)
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
- Trial name
- GSP 301-305 (NCT03463031)
- Testing
- GSP 301 NS
- Where
- 32 sites in United States
- Volunteers
- 446 people
- Sponsor
- Glenmark Specialty S.A.
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Epilepsy With Partial-onset Seizures
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications.
- Trial name
- NCT02477839
- Testing
- Lacosamide
- Where
- 88 sites in United States, Argentina and 24 more
- Volunteers
- 255 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Psoriasis, Atopic Dermatitis
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic…
- Trial name
- NCT01137032
- Testing
- Pandel Cream 0.1%
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Proteinuria
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
- Trial name
- NCT00568178
- Testing
- Losartan Potassium, Comparator: amlodipine besylate
- Volunteers
- 306 people
- Sponsor
- Organon and Co