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Open Label Extension Study Evaluating Sildenafil Citrate When Used In Combination with Epoprostenol In PAH - Article


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Clinical Trial: Open Label Extension Study Evaluating Sildenafil Citrate When Used In Combination with Epoprostenol In PAH

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

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00147641

Purpose

Open label extension study evaluating the effects of sildenafil citrate when used in combination with epoprostenol in the treatment of PAH
Condition Intervention Phase
Pulmonary Hypertension
  Drug: Sildenafil citrate
 Phase III

MedlinePlus related topics:  Pulmonary Hypertension

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: A Multi-Centre, Multinational, Long-Term, Open-Label Extension Study, To Assess the Safety of Subject Optimised Treatment Regimens of Oral Sildenafil When Used In Combination with Intravenous Prostacyclin (Epoprostenol), for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481141.

Further Study Details: 
Primary Outcomes: Safety Efficacy Change in epoprostenol dose
Expected Total Enrollment:  265

Study start: January 2003

Eligibility

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

Inclusion Criteria:

  • Patients need to have completed the 16 week double blind study A1481141

Exclusion Criteria:

  • Any other patients with PAH

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00147641

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; Recruiting

Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21287,  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,  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

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

Tennessee
      Pfizer Investigational Site, Nashville,  Tennessee,  37232,  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,  53226,  United States; Recruiting

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

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

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

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

France
      Pfizer Investigational Site, Strasbourg,  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:  A1481153
Last Updated:  September 6, 2005
Record first received:  September 4, 2005
ClinicalTrials.gov Identifier:  NCT00147641
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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Page Updated: June 1, 2005
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