Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
NCT03431649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2018-02-13
Summary
To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt.
analyze the efficacy and side effects.
Conditions
- Pediatric Pulmonary Hypertension
Interventions
- DRUG
-
Beraprost Sodium
1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
- DRUG
-
Sildenafil Citrate
0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
Sponsors & Collaborators
-
Dr. Soetomo General Hospital
lead OTHER_GOV
Principal Investigators
-
Mahrus Rachman, MD · Dr. Soetomo General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-01
- Primary Completion
- 2017-07-30
- Completion
- 2017-10-30
Countries
- Indonesia
Study Locations
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