The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH

This study has been completed.

First Received: September 8, 2005 Last Updated: April 4, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159861

Purpose

Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Sildenafil citrate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Epoprostenol Epoprostenol sodium Citric acid Sildenafil Sildenafil citrate Sodium Citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The change from Baseline in the total distance walked during the 6-Minute Walk test at Week 16 of the study.

Secondary Outcome Measures:

Safety Standard safety data Efficacy 6-Minute Walk Test BORG Dyspnoea Score WHO Functional Class Quality of Life SF-36 and EQ-5D

Estimated Enrollment:	265
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with pulmonary arterial hypertension caused by primary PAH, associated with connective tissue disease or following surgical repair of a congenital heart lesion

Exclusion Criteria:

PH other than PAH

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159861

Show 54 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure )
Study ID Numbers:	A1481141
Study First Received:	September 8, 2005
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00159861 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Citric Acid
Hematologic Agents
Vascular Diseases
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Epoprostenol
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Chelating Agents
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009