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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03431649

Enrollment

Registered

2018-02-13

Start date

2017-04-01

Completion date

2017-10-30

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Pulmonary Hypertension

Brief 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

Interventions

DRUGBeraprost Sodium

1 mcg /kgbw daily, divided in three dosages orally for 12 weeks

DRUGSildenafil Citrate

0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

the researchers don't know which drug taken by the patient and don't know the previous PA pressure

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure	12 weeks	Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost

Secondary

Measure	Time frame	Description
Emergent Adverse Events	12 weeks	adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026