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

Phase 3

Terminated

• Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension
• Interventions: Drug: Sitaxsentan; Drug: Placebo

• Registration Number: NCT00795639
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2008-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-01-30
• Results First Submitted QC: 2012-01-30
• Results First Posted: 2012-03-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitaxsentan	Sitaxsentan	Monotherapy
Sitaxsentan Placebo	Placebo	Monotherapy

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	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)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇦 Kyiv, Ukraine