Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil
Tracking Information
Start Date ICMJE | March 2009 |
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Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: November 9, 2009) | The primary objective is to evaluate the efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy by determining time to clinical worsening in the treatment of subjects with PAH who have completed Study B1321001. [ Time Frame: Duration of the study. ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: November 20, 2008) | The primary objective is to evaluate the efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy by determining time to clinical worsening in the treatment of subjects with PAH who have completed Study B1321001. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ] |
Change History | Complete list of historical versions of study NCT00796666 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 20, 2008) | The secondary objective is to evaluate the safety and efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy who have completed Study B1321001 by change in 6-Minute Walk Distance, WHO functional class, and SF-36 Health Survey. [ Time Frame: Baseline/Day 1 to Weeks 12, 24, and 48 ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil |
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Official Title ICMJE | A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001. |
Brief Summary | As monotherapy for PAH begins to fail additional therapies are introduced. although co-administration of sitaxsentan and sildenafil is wel tolerated the controlled safety/efficacy database of the combination is limited. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy 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 2012 | ||||
Estimated Primary Completion Date | January 2012 (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 | NCT00796666 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | B1321003 | ||||
Study Sponsor ICMJE | Pfizer | ||||
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Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/