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Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome

NCT01200732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2010-09-14

No results posted yet for this study

Summary

A preliminary observational study by the investigators has shown that tadalafil, a selective phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp), systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this placebo controlled trial was to assess the effect of the drug on exercise capacity and functional class compared to placebo.

Conditions

  • Eisenmenger Syndrome

Interventions

DRUG

Tadalafil, placebo

20mg tablets, 2 tablets Once daily(i.e 40mg once daily) 20mg placebo 2 tablets once daily

Sponsors & Collaborators

  • Govind Ballabh Pant Hospital

    lead OTHER_GOV

Principal Investigators

  • Saibal Mukhopadhyay, M.D;D.M · GBPant Hospital

  • Sanjay Tyagi, M.D;D.M · GBPant Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200732 on ClinicalTrials.gov