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

Study Overview
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Brief Summary
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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
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Open-label extension

Official Title
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A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Sitaxsentan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitaxsentan<br>Sitaxsentan | Drug: Sitaxsentan<br>* Sitaxsentan 100 mg tablets once daily<br>* Other names: Sitaxentan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported. | Day 1 up to 82 months | 
| 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) | ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | 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 | 
| The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | 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 | 
| Percentage of Participants With Total Bilirubin > 1.5 x ULN | Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | 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 | 
| Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | 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 | 
| Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | 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 | 
| Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) | Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | 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 | 
| Percentage of Participants With Anticoagulant Use | Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan. | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | 
| Percentage of Participants With Elevated International Normalize Ratio (INR) | 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. | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | 
| Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance | Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement. | Weeks 28,60,72,84,96,104, Transition Visit up to 82 months | 
| Percentage of Participants With Vital Sign Results of Potential Clinical Importance | Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement. | Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months | 
| Percentage of Participants With Abnormal Prothrombin Time (PT) | PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | 
| Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT) | PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-label study