NCT03431649

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligibility criteria: Inclusion: 1. children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension. 2. free from chronic pulmonary disease 3. never performed any cardiac surgical 4. never got any treatment for PH 5. agree to enroll in this study. Exclusion 1\. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy. Outcome measure: Pulmonary artery pressure

Conditions

• Pediatric Pulmonary Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-07-30
• Completion: 2017-10-30
• First posted: 2018-02-13
• Last updated: 2018-02-13

Locations

1 site across 1 country: Indonesia