Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
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| ClinicalTrials.gov Identifier: NCT03431649 |
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Recruitment Status :
Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pediatric Pulmonary Hypertension | Drug: Beraprost Sodium Drug: Sildenafil Citrate | Phase 4 |
Eligibility criteria:
Inclusion:
- children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension.
- free from chronic pulmonary disease
- never performed any cardiac surgical
- never got any treatment for PH
- 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 (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | the researchers don't know which drug taken by the patient and don't know the previous PA pressure |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect |
| Actual Study Start Date : | April 1, 2017 |
| Actual Primary Completion Date : | July 30, 2017 |
| Actual Study Completion Date : | October 30, 2017 |
| Arm | Intervention/treatment |
|---|---|
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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 Name: Dorner |
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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 Name: Viagra |
- 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
- 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
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| Ages Eligible for Study: | 1 Year to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431649
| Indonesia | |
| Dr. Soetomo General Hospital | |
| Surabaya, East Java, Indonesia | |
| Study Director: | Mahrus Rachman, MD | Dr. Soetomo General Hospital |
Publications:
| Responsible Party: | Dr. dr. Mahrus A. Rahman Sp.A(K), Doctor, Dr. Soetomo General Hospital |
| ClinicalTrials.gov Identifier: | NCT03431649 History of Changes |
| Other Study ID Numbers: |
TAshirley |
| First Posted: | February 13, 2018 Key Record Dates |
| Last Update Posted: | February 13, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 |
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Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Epoprostenol Sildenafil Citrate Beraprost Citric Acid Sodium Citrate Anticoagulants |
Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Urological Agents Platelet Aggregation Inhibitors Antihypertensive Agents |