SR-PAAS - Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil
Tracking Information
Start Date ICMJE | November 2008 |
---|---|
Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: November 20, 2008) | The primary efficacy endpoint is the to evaluate change in the 6MWD. [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00795639 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 20, 2008) | To evaluate the safety and efficacy of sitaxsentan (100 mg dose) as compared to placebo in the treatment of subjects with PAH by determining change from Baseline in WHO functional class and time to clinical worsening. [ Time Frame: Baseline/Day 1 and Weeks 4, 8 and 12 ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | SR-PAAS - Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil |
---|---|
Official Title ICMJE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension. |
Brief Summary | This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the SR-PAAS program. |
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 |
|
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 180 | ||||
---|---|---|---|---|---|
Estimated Completion Date | February 2011 | ||||
Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 16 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
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 | NCT00795639 | ||||
---|---|---|---|---|---|
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | B1321001 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/