A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

This study has been terminated.
(This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00811018
First received: December 9, 2008
Last updated: March 29, 2012
Last verified: November 2011
  Purpose

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Sitaxsentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to 82 months ] [ Designated as safety issue: No ]
    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

  • The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
    ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
    ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • Percentage of Participants With Total Bilirubin > 1.5 x ULN [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
    Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • Percentage of Participants With Laboratory Test Abnormalities (Hematology) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
    Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • Percentage of Participants With Laboratory Test Abnormalities (Chemistry) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
    Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
    Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • Percentage of Participants With Anticoagulant Use [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
    Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.

  • Percentage of Participants With Elevated International Normalize Ratio (INR) [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
    Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.

  • Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance [ Time Frame: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months ] [ Designated as safety issue: No ]
    Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.

  • Percentage of Participants With Vital Sign Results of Potential Clinical Importance [ Time Frame: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months ] [ Designated as safety issue: No ]
    Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.

  • Percentage of Participants With Abnormal Prothrombin Time (PT) [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
    PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  • Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT) [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
    PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.


Enrollment: 1192
Study Start Date: March 2003
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitaxsentan
Sitaxsentan
Drug: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Other Name: Sitaxentan

Detailed Description:

Open-label extension

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
  • Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

  • Has portal hypertension or chronic liver disease.
  • Has history of left sided heart disease or significant cardiac disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811018

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90073
Pfizer Investigational Site
San Francisco, California, United States, 94143-0124
Pfizer Investigational Site
Torrence, California, United States, 90502
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80262
Pfizer Investigational Site
Denver, Colorado, United States, 80218
United States, Florida
Pfizer Investigational Site
Sarasota, Florida, United States, 34233
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
Pfizer Investigational Site
Decatur, Georgia, United States, 30030
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
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, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112-1393
United States, Maine
Pfizer Investigational Site
Portland, Maine, United States, 04102
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02118
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
Pfizer Investigational Site
Boston, Massachusetts, United States, 02218
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0570
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, New Jersey
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903-0019
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
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-5735
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-2650
United States, Texas
Pfizer Investigational Site
Galveston, Texas, United States, 77555-0561
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84143
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, C1416ASA
Pfizer Investigational Site
Capital Federal, Argentina, C1039AAO
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Pfizer Investigational Site
Chermside Q, Queensland, Australia, 4032
Australia, Victoria
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
Australia
Pfizer Investigational Site
Chermside, Australia, QLD 4032
Austria
Pfizer Investigational Site
Graz, Austria, 8036
Pfizer Investigational Site
Wien, Austria, 1090
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Pfizer Investigational Site
Leuven, Belgium, B - 3000
Brazil
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30380-090
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-003
Pfizer Investigational Site
Sao Paulo, Brazil, 05403-000
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T1Y 6J4
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4G5
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4G5
France
Pfizer Investigational Site
Clamart Cedex, France, 92141
Pfizer Investigational Site
GRENOBLE Cedex 09, France, 38043
Pfizer Investigational Site
Strasbourg, France, 67098
Germany
Pfizer Investigational Site
Berlin, Germany, 14050
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Giessen, Germany, 35392
Pfizer Investigational Site
Greifswald, Germany, 17487
Pfizer Investigational Site
Hannover, Germany, 30625
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
Regensburg, Germany, 93053
Israel
Pfizer Investigational Site
Petach Tikva, Israel, 49100
Pfizer Investigational Site
Tel-Hashomer, Ramat Gan, Israel, 52601
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Mexico
Pfizer Investigational Site
Monterrey, CP, Mexico, 64020
Pfizer Investigational Site
Tlalpan, DF, Mexico, 14080
Pfizer Investigational Site
Monterrey, N.l., Mexico, 64360
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Poland
Pfizer Investigational Site
Krakow, Poland, 31-202
Pfizer Investigational Site
Warszawa, Poland, 01-138
Pfizer Investigational Site
Zabrze, Poland, 41-800
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
United Kingdom
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RB
Pfizer Investigational Site
Glasgow, United Kingdom, G11 6NT
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00811018     History of Changes
Other Study ID Numbers: B1321007, FPH03
Study First Received: December 9, 2008
Results First Received: March 29, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Open-label study

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014