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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00811018
• Date of registration: 09/12/2008
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension STRIDE-3
• Scientific title: A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: March 2003
• Target sample size: 1192
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00811018
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Sitaxsentan

Primary Outcome(s)

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]

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]

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]

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]

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]

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]

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]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Day 1 up to 82 months]

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]

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]

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]

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]

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]

Secondary ID(s)

FPH03

B1321007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/04/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00811018