Pediatric Pulmonary HypertensionPhase 4NCT03431649
Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
A Phase 4 study testing Beraprost Sodium and Sildenafil Citrate in people with Pediatric Pulmonary Hypertension, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pediatric Pulmonary Hypertension
- What is being tested?
- Beraprost Sodium and Sildenafil Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2017to 30 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
- agree to enroll in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.
Outcome measure:
Pulmonary artery pressure
- Conditions
- Pediatric Pulmonary Hypertension
- Being tested
- Beraprost Sodium, Sildenafil Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beraprost SodiumDrug
Also called Dorner
1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
Sildenafil CitrateDrug
Also called Viagra
0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Beraprost Sodium | Experimental | 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 Receives: Drug: Beraprost Sodium |
| Sildenafil citrate | Active comparator | 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 Receives: Drug: Sildenafil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Apr 2017
- Primary completion30 Jul 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. dr. Mahrus A. Rahman Sp.A(K), Dr. Soetomo General Hospital
- Investigators
- Mahrus Rachman, MD, Study director, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431649
- Sponsor's protocol ID
- TAshirley
- Status last verified
- Feb 2018
- First submitted
- 29 Jul 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect
- ClinicalTrials.gov ID
- NCT03431649
- Acronym / sponsor ID
- TAshirley
- Conditions
- Pediatric Pulmonary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.
Outcome measure:
Pulmonary artery pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beraprost Sodium | Experimental | Drug: Beraprost SodiumBeraprost 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 comparator | Drug: Sildenafil CitrateSildenafil 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 |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
- agree to enroll in this study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beraprost SodiumAlso: Dorner1 mcg /kgbw daily, divided in three dosages orally for 12 weeks | Drug | Beraprost Sodium |
| Sildenafil CitrateAlso: Viagra0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks | Drug | Sildenafil citrate |
Primary outcome
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
1 secondary outcome
Emergent Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 16132278Limsuwan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Pulmonary Hypertension
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Recruiting
MedlyPeds Feasibility Study
Pediatric Heart Failure, Congenital Heart Disease (CHD)
Recruiting
iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
Pulmonary Hypertension
RecruitingObservational study
Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes
Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahrus Rachman, MD study director
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beraprost Sodium and Sildenafil Citrate in people with Pediatric Pulmonary Hypertension, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.