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

  Show 91 Study Locations
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 16, 2014