A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
- Registration Number
- NCT00811018
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Open-label extension
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1192
- 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.
- Has portal hypertension or chronic liver disease.
- Has history of left sided heart disease or significant cardiac disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sitaxsentan Sitaxsentan Sitaxsentan
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) 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.
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) 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.
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN 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.
Percentage of Participants With Total Bilirubin > 1.5 x ULN 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.
Percentage of Participants With Laboratory Test Abnormalities (Hematology) 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.
Percentage of Participants With Laboratory Test Abnormalities (Chemistry) 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.
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) 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.
Percentage of Participants With Anticoagulant Use 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.
Percentage of Participants With Elevated International Normalize Ratio (INR) 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.
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance 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.
Percentage of Participants With Vital Sign Results of Potential Clinical Importance 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.
Percentage of Participants With Abnormal Prothrombin Time (PT) 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.
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Newcastle, United Kingdom