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CompletedNCT03431649Updated Feb 13, 2018

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

A Phase 4 interventional study of Beraprost Sodium and Sildenafil Citrate in Pediatric Pulmonary Hypertension, sponsored by Dr. Soetomo General Hospital. Completed at 1 site in Indonesia. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Dr. Soetomo General Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2017, registered Jul 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Year to 17 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Pediatric Pulmonary Hypertension
03

In context

Lead sponsor

Dr. Soetomo General Hospital is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugBeraprost Sodium

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

    Also known as: Dorner

  • DrugSildenafil Citrate

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

    Also known as: Viagra

06

What researchers measure

Primary outcomes

  1. Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure

    Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost

    Time frame: 12 weeks

Secondary outcomes

  1. Emergent Adverse Events

    adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding

    Time frame: 12 weeks

07

Study locations

1 site
  • Dr. Soetomo General Hospital
    Surabaya, East Java, Indonesia
08

References and documents

Publications

  • Limsuwan A, Pienvichit P, Khowsathit P. Beraprost therapy in children with pulmonary hypertension secondary to congenital heart disease. Pediatr Cardiol. 2005 Nov-Dec;26(6):787-91. doi: 10.1007/s00246-005-0925-4. PubMed 16132278 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Jul 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2017
First posted
Feb 13, 2018
StartActual
Apr 1, 2017
Primary completionActual
Jul 30, 2017
CompletionActual
Oct 30, 2017
Last update
Feb 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03431649
Lead sponsor
Dr. Soetomo General Hospital
Responsible party
Dr. dr. Mahrus A. Rahman Sp.A(K) (Doctor, Dr. Soetomo General Hospital) — Principal investigator
First posted
Feb 13, 2018
Start date
Apr 1, 2017
Primary completion
Jul 30, 2017
Completion
Oct 30, 2017
Last update
Feb 13, 2018

Study contacts

Mahrus Rachman, MD
study director · Dr. Soetomo General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Beraprost

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Dr. Soetomo General Hospital

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