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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01200732 |
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Date of registration:
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08/09/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome
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Scientific title:
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Clinical Efficacy of Phosphodiesterase-5 Inhibitor Tadalafil in Eisenmenger Syndrome - A Randomised, Placebo Controlled, Double Blind, Crossover Study |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01200732 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Saibal Mukhopadhyay, M.D;D.M |
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Address:
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Telephone:
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Email:
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Affiliation:
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GBPant Hospital |
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Name:
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Sanjay Tyagi, M.D;D.M |
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Address:
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Telephone:
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Email:
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Affiliation:
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GBPant Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of ES with age greater than or equal to 14 years and weight greater than or
equal to 30 kgs in World Health Organisation (WHO) functional class II and III
attending our congenital clinic were invited to participate in the study
Exclusion Criteria:
- WHO class IV,
- congestive heart failure or had PCWP > 15mmHg,
- left ventricular ejection fraction <40%,
- atrial fibrillation,
- patent ductus arteriosus,
- complex congenital heart defects,
- restrictive lung disease(total lung capacity < 70% of predicted), obstructive
lung disease ( forced expiratory volume in 1 second [FEV1] < 70% of predicted with
FEV1/ Forced vital capacity [FVC] < 60%),
- previously diagnosed coronary artery disease requiring nitrate therapy,
- abnormal biochemical profile and
- hypersensitivity to PDE- 5 inhibitors.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Eisenmenger Syndrome
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Intervention(s)
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Drug: Tadalafil, placebo
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Primary Outcome(s)
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The primary end point of efficacy was improvement in exercise tolerance as assessed by the un-encouraged 6 minute walk test (6MWT) compared to baseline after 6 weeks of treatment
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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The secondary endpoints were effect of the drug on pulmonary vascular resistance (PVR).
[Time Frame: 6 weeks]
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The secondary endpoints were effect of the drug on effective pulmonary blood flow(EPBF)
[Time Frame: 6 weeks]
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The secondary endpoints were effect of the drug on systemic vascular resistance (SVR)
[Time Frame: 6 weeks]
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The secondary endpoints were effect of the drug on systemic oxygen saturation (SaO2)
[Time Frame: 6 weeks]
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The secondary endpoints were effect of the drug on WHO functional class
[Time Frame: 6 weeks]
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Secondary ID(s)
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ES/F.501(134)/EC/07/MC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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