Clinical trials: Pediatric Cardiology
Hypotension
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children.
- Trial name
- NCT00135668
- Testing
- Nitroprusside
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- The Emmes Company, LLC
Hypertension, Pulmonary
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months.
- Trial name
- NCT01342952
- Testing
- Ambrisentan
- Where
- 22 sites in United States, Argentina and 7 more
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
- Trial name
- NCT03255226
- Testing
- Tolvaptan
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyperemia
Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants.
- Trial name
- NCT01959243
- Testing
- Brimonidine Tartrate, Vehicle, Sodium Fluorescein
- Where
- 4 sites in United States
- Volunteers
- 507 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Venous Thromboembolism
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
- Trial name
- NCT05966740
- Where
- 10 sites in United States
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Hypertension
52-104 Week Off-therapy Second Extension to Study CSPP100A2365
52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and development in pediatric hypertensive patients previously treated with aliskiren in studies SPP100A2365 and SPP100A2365E1
- Trial name
- NCT01420068
- Testing
- SPP100
- Where
- 25 sites in United States, Guatemala and 5 more
- Volunteers
- 106 people
- Sponsor
- LXO Group
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Heart Failure
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2…
- Trial name
- NCT03785405
- Testing
- sacubitril/valsartan
- Where
- 79 sites in United States, Argentina and 25 more
- Volunteers
- 216 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses.
- Trial name
- NCT01150357
- Testing
- Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg), Aliskiren (150/300/600 mg)
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 267 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension, Chronic Kidney Disease
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.
- Trial name
- NCT01365481
- Testing
- Valsartan, amlodipine, Hydrochlorothiazide
- Where
- 28 sites in Colombia, Finland and 8 more
- Volunteers
- 150 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension, Pulmonary
Efficacy and Safety of Ambrisentan in Children 8-18yrs
A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary…
- Trial name
- NCT01332331
- Testing
- Ambrisentan - low dose, Ambrisentan - high dose
- Where
- 24 sites in United States, Argentina and 7 more
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Venous Thromboembolism
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
- Trial name
- NCT02464969
- Testing
- Apixaban, Standard of Care
- Where
- 128 sites in United States, Australia and 11 more
- Volunteers
- 229 people
- Sponsor
- Bristol-Myers Squibb
Hereditary Angioedema (HAE)
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in…
- Trial name
- NCT01386658
- Testing
- icatibant
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 32 people
- Sponsor
- Shire
Thrombosis
Pediatric Catheter-related Thrombosis Imaging Study
This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection of catheter related deep…
- Trial name
- AESOP (NCT01137578)
- Testing
- Ultrasound, Magnetic Resonance Imaging with Contrast, Magnetic Resonance Imaging without Contrast
- Where
- 26 sites in United States, Argentina and 7 more
- Volunteers
- 151 people
- Sponsor
- Bristol-Myers Squibb
Pulmonary Arterial Hypertension, Hypertension, Pulmonary
Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease. In many patients, the course of PAH is a steady deterioration and reduced life expectancy.
- Trial name
- NCT01642407
- Testing
- Sildenafil
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Granulomatosis With Polyangiitis
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA)…
- Trial name
- NCT01750697
- Testing
- Rituximab
- Where
- 23 sites in United States, Canada and 6 more
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
Heart Defects, Congenital
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle.
- Trial name
- EC-TCPC (NCT02377674)
- Testing
- Vascular Graft, Model COR-VG-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Fabry Disease
Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease
This is a long-term, Open-label Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Migalastat in Subjects > 12 Years of Age With Fabry Disease and Amenable GLA Variants
- Trial name
- NCT04049760
- Testing
- migalastat HCl 150 mg
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Amicus Therapeutics