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

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ClinicalTrials.gov Identifier: NCT00811018
Recruitment Status : Terminated (This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.)
First Posted : December 18, 2008
Results First Posted : April 24, 2012
Last Update Posted : April 24, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Sitaxsentan Phase 3

Detailed Description:
Open-label extension
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1192 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension
Study Start Date : March 2003
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sitaxsentan
Sitaxsentan
 Drug: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Other Name: Sitaxentan


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to 82 months ]
    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

  2. 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 ]
    ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  3. 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 ]
    ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  4. 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 ]
    Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  5. 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 ]
    Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  6. 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 ]
    Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  7. 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 ]
    Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  8. 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 ]
    Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.

  9. 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 ]
    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.

  10. 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 ]
    Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.

  11. 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 ]
    Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.

  12. 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 ]
    PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  13. 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 ]
    PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811018


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00811018    
Other Study ID Numbers: B1321007
FPH03
First Posted: December 18, 2008    Key Record Dates
Results First Posted: April 24, 2012
Last Update Posted: April 24, 2012
Last Verified: November 2011
Keywords provided by Pfizer:
Open-label study
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
 Lung Diseases
Respiratory Tract Diseases
Sitaxsentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action