Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

February 12, 2018 updated by: Dr. dr. Mahrus A. Rahman Sp.A(K), Dr. Soetomo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia
        • Dr. Soetomo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Beraprost Sodium
1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
Other Names:
  • Dorner
Active Comparator: 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
Drug: Sildenafil Citrate
0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
Other Names:
  • Viagra

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Soetomo General Hospital

Investigators

  • Study Director: Mahrus Rachman, MD, Dr. Soetomo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

July 29, 2017

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAshirley

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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