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

December 9, 2008
March 29, 2012
March 2003
July 2011   (final data collection date for primary outcome measure)
  • 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.
The primary objective of this study is to evaluate the long-term safety of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH. [ Time Frame: At study completion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00811018 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

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.

Open-label extension

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pulmonary Arterial Hypertension
Drug: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Other Name: Sitaxentan
Experimental: Sitaxsentan
Sitaxsentan
Intervention: Drug: Sitaxsentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1192
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Spain,   United Kingdom
 
NCT00811018
B1321007, FPH03
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP