Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03431649
• Date of registration: 29/07/2017
• Prospective Registration: No
• Primary sponsor: Dr. Soetomo General Hospital
• Public title: Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
• Scientific title: Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect
• Date of first enrolment: April 1, 2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03431649
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Indonesia

Contacts

• Name: Mahrus Rachman, MD
• Affiliation: Dr. Soetomo General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and
combination)

- agree to enroll in this study

Exclusion Criteria:

- suffer from chronic lung disease

- suffer from soft tissue tumor, HIV/AIDS

- under interferon therapy

- already performed any cardiac surgery

- already got anti-PH remedy



Age minimum: 1 Year
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pediatric Pulmonary Hypertension

Intervention(s)

Drug: Sildenafil Citrate

Drug: Beraprost Sodium

Primary Outcome(s)

Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure [Time Frame: 12 weeks]

Secondary Outcome(s)

Emergent Adverse Events [Time Frame: 12 weeks]

Secondary ID(s)

TAshirley

Source(s) of Monetary Support

Please refer to primary and secondary sponsors