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The Efficacy and Safety of Sildenafil Citrate Used in Combination with Intravenous Epoprostenol in PAH - Article


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Hypertension

High Blood Pressure; Hypertension/High Blood Pressure 



Clinical Trial: The Efficacy and Safety of Sildenafil Citrate Used in Combination with Intravenous Epoprostenol in PAH

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: 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

MedlinePlus related topics:  Pulmonary Hypertension

Study Type: Interventional
Study Design: Educational/Counseling/Training, 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.

Further Study Details: 
Primary Outcomes: The change from Baseline in the total distance walked during the 6-Minute Walk test at Week 16 of the study.
Secondary Outcomes: Secondary Endpoints:; 1. Change from Baseline at Week 16 in mean Pulmonary Artery Pressure (mPAP).; 2. Time from randomisation to the first occurrence of clinical worsening defined as death or lung transplantation or hospitalisation due to PAH
Expected Total Enrollment:  265

Study start: October 2002

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • PH other than PAH

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00159861

Pfizer CT.gov Call Center      1-800-718-1021 

California
      Pfizer Investigational Site, Torrance,  California,  90502,  United States; Recruiting

      Pfizer Investigational Site, Torrance,  California,  90509,  United States; Recruiting

      Pfizer Investigational Site, Torrence,  California,  90502,  United States; Recruiting

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

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

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

Colorado
      Pfizer Investigational Site, Denver,  Colorado,  80262,  United States; Recruiting

Illinois
      Pfizer Investigational Site, Chicago,  Illinois,  60637,  United States; Recruiting

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

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

Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21205,  United States; Recruiting

Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02114,  United States; Recruiting

      Pfizer Investigational Site, Boston,  Massachusetts,  02111,  United States; Recruiting

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

Minnesota
      Pfizer Investigational Site, Rochester,  Minnesota,  55905,  United States; Recruiting

      Pfizer Investigational Site, Minneapolis,  Minnesota,  55407,  United States; No longer recruiting

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

Nebraska
      Pfizer Investigational Site, Omaha,  Nebraska,  68105,  United States; Recruiting

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

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

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

Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44195,  United States; Recruiting

      Pfizer Investigational Site, Cincinnati,  Ohio,  45219,  United States; Recruiting

      Pfizer Investigational Site, Cincinnati,  Ohio,  45219,  United States; Recruiting

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

Pennsylvania
      Pfizer Investigational Site, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting

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

Tennessee
      Pfizer Investigational Site, Nashville,  Tennessee,  37232,  United States; Recruiting

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

Texas
      Pfizer Investigational Site, Houston,  Texas,  77030,  United States; Recruiting

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

Wisconsin
      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53277,  United States; Recruiting

      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Belgium
      Pfizer Investigational Site, Leuven,  3000,  Belgium; Recruiting

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

Canada, British Columbia
      Pfizer Investigational Site, Vancouver,  British Columbia,  V5Z-3J5,  Canada; No longer recruiting

Canada, Ontario
      Pfizer Investigational Site, Toronto,  Ontario,  M5G 2C4,  Canada; Recruiting

      Pfizer Investigational Site, London,  Ontario,  N6A 4G5,  Canada; No longer recruiting

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

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

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

Czech Republic
      Pfizer Investigational Site, PRAGUE 2,  128 08,  Czech Republic; Recruiting

Denmark
      Pfizer Investigational Site, Kobenhavn,  2100,  Denmark; Recruiting

France
      Pfizer Investigational Site, Strasbourg Cedex 02,  67098,  France; Recruiting

      Pfizer Investigational Site, Grenoble Cedex 09,  38043,  France; Recruiting

      Pfizer Investigational Site, Clamart Cedex,  92141,  France; Recruiting

Israel
      Pfizer Investigational Site, Petach Tikva,  49100,  Israel; Recruiting

Italy
      Pfizer Investigational Site, Bologna,  40138,  Italy; Recruiting

Netherlands
      Pfizer Investigational Site, Amsterdam,  1081 HV,  Netherlands; Recruiting

      Pfizer Investigational Site, Nieuwegein,  3435CM,  Netherlands; Recruiting

Spain
      Pfizer Investigational Site, Barcelona,  08036,  Spain; Recruiting

      Pfizer Investigational Site, Madrid,  28041,  Spain; Recruiting

United Kingdom
      Pfizer Investigational Site, Glasgow,  G11 6NT,  United Kingdom; Recruiting

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

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A1481141
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159861
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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