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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Sildenafil citrate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Categorized Change From Baseline in 6-Minute Walking Distance

Secondary outcome:

Survival Status

Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class

Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)

Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score

Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score

Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score

Change From Baseline in BORG Dyspnea Score

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, Prague 2 128 08, Czech Republic

Pfizer Investigational Site, Kobenhavn 2100, Denmark

Pfizer Investigational Site, Clamart Cedex 92141, France

Pfizer Investigational Site, Grenoble Cedex 09 38043, France

Pfizer Investigational Site, Vandoeuvre Les Nancy, France

Pfizer Investigational Site, Petach Tikva 49100, Israel

Pfizer Investigational Site, Bologna 40138, Italy

Pfizer Investigational Site, Amsterdam 1081 HV, Netherlands

Pfizer Investigational Site, Nieuwegein 3435CM, Netherlands

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Madrid 28041, Spain

Pfizer Investigational Site, Glasgow G11 6NT, United Kingdom

Pfizer Investigational Site, Edmonton, Alberta T6G 2B7, Canada

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, Los Angeles, California 90033, United States

Pfizer Investigational Site, Los Angeles, California 90073, United States

Pfizer Investigational Site, San Diego, California 92103, United States

Pfizer Investigational Site, Torrance, California 90502, United States

Pfizer Investigational Site, Torrance, California 90509, United States

Pfizer Investigational Site, Papworth Everard, Cambridgeshire CB3 8RE, United Kingdom

Pfizer Investigational Site, Denver, Colorado 80220, United States

Pfizer Investigational Site, Denver, Colorado 80262, United States

Pfizer Investigational Site, Chicago, Illinois 60637, United States

Pfizer Investigational Site, Kansas City, Kansas 66160, United States

Pfizer Investigational Site, New Orleans, Louisiana 70112, United States

Pfizer Investigational Site, Baltimore, Maryland 21287, United States

Pfizer Investigational Site, Boston, Massachusetts 02114, United States

Pfizer Investigational Site, Boston, Massachusetts 02111, United States

Pfizer Investigational Site, Ann Arbor, Michigan 48109, United States

Pfizer Investigational Site, Rochester, Minnesota 55905, United States

Pfizer Investigational Site, St. Louis, Missouri 63110, United States

Pfizer Investigational Site, Omaha, Nebraska 68105, United States

Pfizer Investigational Site, Omaha, Nebraska 68198-2125, United States

Pfizer Investigational Site, New York, New York 10032, United States

Pfizer Investigational Site, Durham, North Carolina 27710, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Cincinnati, Ohio 45267-0769, United States

Pfizer Investigational Site, Cleveland, Ohio 44195, United States

Pfizer Investigational Site, Ottawa, Ontario K1Y 4W7, Canada

Pfizer Investigational Site, Ottawa, Ontario K1Y 4E9, Canada

Pfizer Investigational Site, Toronto, Ontario M5G 2N2, Canada

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213, United States

Pfizer Investigational Site, Montreal, Quebec H3T 1E2, Canada

Pfizer Investigational Site, Providence, Rhode Island 02903, United States

Pfizer Investigational Site, Nashville, Tennessee 37232-5735, United States

Pfizer Investigational Site, Nashville, Tennessee 37232, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Salt Lake City, Utah 84143, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53215, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53226, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53277, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2003
Last updated: December 20, 2013

Page last updated: August 23, 2015

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