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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Pulmonary Hypertension Drug: Sitaxsentan Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Primary Completion Date : March 2011
Study Completion Date : March 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: Sitaxsentan
Monotherapy
Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
Placebo Comparator: Sitaxsentan Placebo
Monotherapy
Drug: Placebo
Sitaxsentan Placebo = 1 tablet administered orally, once daily
Other Name: Sitaxsentan Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

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


  Show 85 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00795639     History of Changes
Other Study ID Numbers: B1321001
First Posted: November 21, 2008    Key Record Dates
Results First Posted: March 1, 2012
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Pfizer:
Sitaxsentan
endothelin receptor antagonist

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sitaxsentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action