Open-label Study Providing Monotherapy (Sitaxsentan) and Combination Therapy (Sitaxsentan+Sildenafil) to Subjects With PAH to Assess Long-term Safety
Tracking Information
Start Date ICMJE | December 2009 |
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Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: November 20, 2008) | The primary objective is to evaluate the long-term safety in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00796510 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 20, 2008) | The secondary objective is to evaluate the efficacy in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003 by determining change in 6MWD. [ Time Frame: Baseline/Day 1 to Weeks 12 and 24 ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Open-label Study Providing Monotherapy (Sitaxsentan) and Combination Therapy (Sitaxsentan+Sildenafil) to Subjects With PAH to Assess Long-term Safety |
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Official Title ICMJE | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension. |
Brief Summary | As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for PAH therapy is these two oral drugs administered in combination. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 180 | ||||
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Estimated Completion Date | January 2014 | ||||
Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 16 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Bulgaria, Chile, Colombia, Czech Republic, Dominican Republic, India, Romania, Russian Federation, Serbia, Slovakia, South Africa, Thailand |
Administrative Information
NCT ID ICMJE | NCT00796510 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | B1321002 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/