Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2018
CompletedFebruary 13, 2018
February 1, 2018
4 months
July 29, 2017
February 12, 2018
Conditions
Outcome Measures
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
12 weeks
Secondary Outcomes (1)
Emergent Adverse Events
12 weeks
Study Arms (2)
Beraprost Sodium
EXPERIMENTALBeraprost 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
Sildenafil citrate
ACTIVE COMPARATORSildenafil 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
Interventions
1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
Eligibility Criteria
You may qualify if:
- diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
- agree to enroll in this study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
Related Publications (1)
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.
PMID: 16132278BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mahrus Rachman, MD
Dr. Soetomo General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- the researchers don't know which drug taken by the patient and don't know the previous PA pressure
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 29, 2017
First Posted
February 13, 2018
Study Start
April 1, 2017
Primary Completion
July 30, 2017
Study Completion
October 30, 2017
Last Updated
February 13, 2018
Record last verified: 2018-02