Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-10-30

Brief Summary

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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.

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Detailed Description

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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

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Pediatric Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Beraprost Sodium

Beraprost 1mcg/kg/day, divided in 3 doses orally patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study.

22 patients

Group Type EXPERIMENTAL

Beraprost Sodium

Intervention Type DRUG

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

Sildenafil citrate

Sildenafil 0.4 mg/kg/time, 4 times daily per oral patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study.

20 patients

Group Type ACTIVE_COMPARATOR

Sildenafil Citrate

Intervention Type DRUG

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

Interventions

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Beraprost Sodium

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

Intervention Type DRUG

Sildenafil Citrate

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

Intervention Type DRUG

Other Intervention Names

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Dorner Viagra

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No