Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

• ClinicalTrials.gov Identifier: NCT00795639
• Recruitment Status: Terminated
• First Posted: November 21, 2008
• Results First Posted: March 1, 2012
• Last Update Posted: March 24, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 20, 2008
• First Posted Date: November 21, 2008
• Results First Submitted Date: January 30, 2012
• Results First Posted Date: March 1, 2012
• Last Update Posted Date: March 24, 2015
• Study Start Date: December 2008
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2012)

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.

• Original Primary Outcome Measures (submitted: November 20, 2008): The primary efficacy endpoint is the to evaluate change in the 6MWD. [ Time Frame: Baseline to Week 12 ]

Current Secondary Outcome Measures (submitted: March 14, 2012)

• 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.

• Original Secondary Outcome Measures (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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
• 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
• Brief Summary: This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

• Drug: Sitaxsentan
  Sitaxsentan = 100 mg tablet administered orally, once daily
• Drug: Placebo
  Sitaxsentan Placebo = 1 tablet administered orally, once daily
  Other Name: Sitaxsentan Placebo

Study Arms

• Experimental: Sitaxsentan
  Monotherapy
  Intervention: Drug: Sitaxsentan
• Placebo Comparator: Sitaxsentan Placebo
  Monotherapy
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 18, 2011): 183
• Original Estimated Enrollment (submitted: November 20, 2008): 180
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.

Exclusion Criteria:

• Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Bulgaria, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Guatemala, India, Malaysia, Mexico, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Thailand, Turkey, Ukraine, United States
• Removed Location Countries: Egypt, Jordan, Lebanon, United Arab Emirates

Administrative Information

• NCT Number: NCT00795639
• Other Study ID Numbers: B1321001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2015