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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

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Torrance, California, United States, 90502
Pfizer Investigational Site
Torrance, California, United States, 90509
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Los Angeles, California, United States, 90073
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
San Diego, California, United States, 92103
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80220
Pfizer Investigational Site
Denver, Colorado, United States, 80262
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68105
Pfizer Investigational Site
Omaha, Nebraska, United States, 68198-2125
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
CLEVELAND, Ohio, United States, 44195
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
CINCINNATI, Ohio, United States, 45219
Pfizer Investigational Site
CINCINNATI, Ohio, United States, 45267-0769
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02903
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-5735
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
HOUSTON, Texas, United States, 77030
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84143
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53277
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Belgium
Pfizer Investigational Site
Leuven, Belgium, 3000
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1Y 4E9
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
Pfizer Investigational Site
Prague 2, Czech Republic, 128 08
Denmark
Pfizer Investigational Site
Kobenhavn, Denmark, 2100
France
Pfizer Investigational Site
Grenoble Cedex 09, France, 38043
Pfizer Investigational Site
Clamart Cedex, France, 92141
France, 54511
Pfizer Investigational Site
VANDOEUVRE LES NANCY, 54511, France
Israel
Pfizer Investigational Site
Petach Tikva, Israel, 49100
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Pfizer Investigational Site
Nieuwegein, Netherlands, 3435CM
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
MADRID, Spain, 28041
United Kingdom
Pfizer Investigational Site
Glasgow, United Kingdom, G11 6NT
United Kingdom, Cambridgeshire
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RE
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 27, 2009



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