Clinical trials: Pediatric Cardiology
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
Syncope, Pediatric
Pediatric Adhesion and New Dermal Approach Study
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality.
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease
- Trial name
- PANDA (NCT07118124)
- Testing
- Zio monitor
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- iRhythm Technologies, Inc.
Patent Ductus Arteriosus
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects…
- Trial name
- NCT05264753
- Testing
- Occlutech® PDA Occluder
- Where
- 15 sites in Canada, France and 7 more
- Volunteers
- 255 people
- Sponsor
- Occlutech International AB
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Venous Thromboembolism
An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism
This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.
- Trial name
- NCT06278051
- Testing
- Rivaroxaban granules for oral suspension, Warfarin
- Where
- 2 sites in Japan
- Volunteers
- 320 people
- Sponsor
- Bayer
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
Hemodynamic Monitoring
Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters
This study will test the use of the UltraTrac™ system, a small, noninvasive device that uses electrodes on the skin and a small ultrasound sensor to provide measurements of cardiac function in a wide of subjects.
- Trial name
- NCT07862608
- Testing
- Noninvasive Hemodynamic Monitoring System
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- AcQumen Medical, Inc.
Hereditary Angioedema (HAE)
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE).
- Trial name
- NCT05509569
- Testing
- Icatibant
- Where
- Japan
- Volunteers
- 32 people
- Sponsor
- Takeda
Kawasaki Disease
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
- Trial name
- NCT00162045
- Testing
- Technetium Tc99m Sestamibi
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 79 people
- Sponsor
- Lantheus Medical Imaging
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
Kawasaki Disease
Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
- Trial name
- NCT01524939
- Testing
- immunoglobulin G
- Where
- 7 sites in South Korea
- Volunteers
- 45 people
- Sponsor
- Green Cross Corporation
Hypertension
A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents.
- Trial name
- NCT00171041
- Testing
- valsartan
- Where
- 2 sites in United States, Germany
- Volunteers
- 265 people
- Sponsor
- Novartis
Hypertension
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
- Trial name
- NCT00834041
- Testing
- Aliskiren 3.125 mini-tablets
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Novartis
Aphakia
Artisan Aphakia Lens for the Correction of Aphakia in Children
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
- Trial name
- NCT01547442
- Testing
- Artisan Aphakia Intraocular Lens
- Where
- 19 sites in United States, Canada
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Ophtec USA
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Hereditary Angioedema
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab.
- Trial name
- SPRING (NCT04070326)
- Testing
- Lanadelumab
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 21 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE…
- Trial name
- NCT07159464
- Testing
- CSL312
- Sponsor
- CSL Behring
Hypertension
Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject characteristics and…
- Trial name
- NCT00244595
- Testing
- candsartan cilexetil
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 235 people
- Sponsor
- AstraZeneca
Pulmonary Arterial Hypertension, Dilated Cardiomyopathy
IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in pediatric, adolescent and adult patients with congenital heart disease associated pulmonary arterial…
- Conditions
- Pulmonary Arterial Hypertension, Dilated Cardiomyopathy, Congenital Heart Disease
- Trial name
- HEARTFUL-CHD (NCT06072937)
- Testing
- IntelliStent
- Volunteers
- 10 people
- Sponsor
- HeartPoint Global
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.