Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
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|ClinicalTrials.gov Identifier: NCT00795639|
Recruitment Status : Terminated (Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)
First Posted : November 21, 2008
Results First Posted : March 1, 2012
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Pulmonary Hypertension||Drug: Sitaxsentan Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Sitaxsentan = 100 mg tablet administered orally, once daily
Placebo Comparator: Sitaxsentan Placebo
Sitaxsentan Placebo = 1 tablet administered orally, once daily
Other Name: Sitaxsentan Placebo
- Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12 [ Time Frame: Baseline/Day 1 and Week 12 ]6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.
- Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12 [ Time Frame: Baseline, Weeks 4, 8 and 12 or Early Termination (ET) ]WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.
- Time to Clinical Worsening (TTCW) [ Time Frame: Baseline, Weeks 4, 8 and 12 or ET ]TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795639
|Study Director:||Pfizer CT.gov Call Center||Pfizer|