Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Sildenafil citrate	Phase III

Further Study Details: 

Primary Outcomes: Safety; Standard safety data; Efficacy; 6-Minute Walk test at each visit; BORG Dyspnoea score at each visit; Pulmonary hypertension criteria for functional capacity and therapeutic class assessment at each visit; Quality of life, as measured by the SF-36
Expected Total Enrollment:  278

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria:

• Any other patients with PAH that had not been included into the pivotal study

Please refer to this study by ClinicalTrials.gov identifier  NCT00159887

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

Alabama
      Pfizer Investigational Site, Birmingham,  Alabama,  35233,  United States; Recruiting
      Pfizer Investigational Site, Birmingham,  Alabama,  35294,  United States; Recruiting
      Pfizer Investigational Site, Birmingham,  Alabama,  35294-0006,  United States; Recruiting
California
      Pfizer Investigational Site, La Jolla,  California,  92037,  United States; Recruiting
      Pfizer Investigational Site, La Jolla,  California,  92093,  United States; Recruiting
      Pfizer Investigational Site, San Diego,  California,  92103,  United States; Recruiting
      Pfizer Investigational Site, Torrance,  California,  90502,  United States; Recruiting
      Pfizer Investigational Site, Torrance,  California,  90509,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90024,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90095,  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
Louisiana
      Pfizer Investigational Site, Shreveport,  Louisiana,  71103,  United States; No longer recruiting
Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21287,  United States; Recruiting
Massachusetts
      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
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
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
Wisconsin
      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53215,  United States; Recruiting
Australia, New South Wales
      Pfizer Investigational Site, Darlinghurst,  New South Wales,  2010,  Australia; Recruiting
Australia, Victoria
      Pfizer Investigational Site, Melbourne,  Victoria,  3004,  Australia; Recruiting
Belgium
      Pfizer Investigational Site, BRUXELLES,  1070,  Belgium; Recruiting
      Pfizer Investigational Site, Leuven,  3000,  Belgium; Recruiting
Brazil, SP
      Pfizer Investigational Site, Sao Paulo,  SP,  05403-900,  Brazil; Recruiting
Czech Republic
      Pfizer Investigational Site, PRAGUE 4,  140 00,  Czech Republic; Recruiting
      Pfizer Investigational Site, PRAGUE 4,  140 21,  Czech Republic; Recruiting
Denmark
      Pfizer Investigational Site, Kobenhavn,  2100,  Denmark; Recruiting
France
      Pfizer Investigational Site, Clamart Cedex,  92141,  France; Recruiting
Germany
      Pfizer Investigational Site, Giessen,  35385,  Germany; Recruiting
      Pfizer Investigational Site, Giessen,  35392,  Germany; Recruiting
      Pfizer Investigational Site, Leipzig,  04103,  Germany; Recruiting
      Pfizer Investigational Site, Hannover,  30625,  Germany; Recruiting
Hong Kong
      Pfizer Investigational Site, Shatin NT,  Hong Kong; Recruiting
Hungary, Pest
      Pfizer Investigational Site, Budapest,  Pest,  1529,  Hungary; Recruiting
Hungary, Zala
      Pfizer Investigational Site, Zalaegerszeg,  Zala,  8900,  Hungary; No longer recruiting
Israel
      Pfizer Investigational Site, Tel Hashomer,  52621,  Israel; Recruiting
      Pfizer Investigational Site, Petach Tikva,  49100,  Israel; Recruiting
Italy
      Pfizer Investigational Site, Bologna,  40138,  Italy; Recruiting
      Pfizer Investigational Site, Pisa,  56124,  Italy; Recruiting
      Pfizer Investigational Site, Pisa,  56126,  Italy; Recruiting
Korea, Republic of
      Pfizer Investigational Site, Suwon,  442-721,  Korea, Republic of; Recruiting
Malaysia
      Pfizer Investigational Site, Kuala Lumpur,  59100,  Malaysia; Recruiting
Mexico, DF
      Pfizer Investigational Site, Tlalpan Mexico,  DF,  14050,  Mexico; Recruiting
Mexico, Mexico DF
      Pfizer Investigational Site, Tlalpan,  Mexico DF,  14080,  Mexico; Recruiting
Netherlands
      Pfizer Investigational Site, Amsterdam,  1081 HV,  Netherlands; Recruiting
Poland
      Pfizer Investigational Site, Zabrze,  41-800,  Poland; Recruiting
      Pfizer Investigational Site, Warszawa,  01-138,  Poland; Recruiting
Singapore
      Pfizer Investigational Site, Singapore,  168752,  Singapore; Recruiting
South Africa
      Pfizer Investigational Site, Johannesburg,  2193,  South Africa; Recruiting
South Africa, 7500
      Pfizer Investigational Site, Parow,  7500,  South Africa; Recruiting
Spain
      Pfizer Investigational Site, Barcelona,  08036,  Spain; Recruiting
      Pfizer Investigational Site, Barcelona,  08035,  Spain; Recruiting
      Pfizer Investigational Site, Madrid,  28041,  Spain; Recruiting
Sweden
      Pfizer Investigational Site, Goteborg,  413 45,  Sweden; Recruiting
      Pfizer Investigational Site, GOTHENBURG,  41345,  Sweden; Recruiting
      Pfizer Investigational Site, Molndal,  431 80,  Sweden; 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
United Kingdom, South Yorkshire
      Pfizer Investigational Site, Sheffield,  South Yorkshire,  S10 2JF,  United Kingdom; Recruiting
United Kingdom, Tyne and Wear
      Pfizer Investigational Site, Newcastle upon Tyne,  Tyne and Wear,  NE7 7DN,  United Kingdom; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1481142
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159887
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13