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

March 4, 2015 updated by: Pfizer

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1039AAO
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1428DCO
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1428DUS
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1431FWO
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1202
        • Pfizer Investigational Site
      • Veliko Turnovo, Bulgaria, 5000
        • Pfizer Investigational Site
  • Chile
      • Temuco, Chile, 4781173
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100032
        • Pfizer Investigational Site
      • Shanghai, China, 200001
        • Pfizer Investigational Site
      • Shanghai, China, 200433
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Pfizer Investigational Site
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Pfizer Investigational Site
  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Costa Rica
    • San Jose
      • Escazu, San Jose, Costa Rica, 00000
        • Pfizer Investigational Site
  • Czech Republic
      • Praha 2, Czech Republic, 128 08
        • Pfizer Investigational Site
  • Dominican Republic
      • Santo Domingo, Dominican Republic, 4966
        • Pfizer Investigational Site
    • República Dominicana
      • Santo Domingo, República Dominicana, Dominican Republic, 00000
        • Pfizer Investigational Site
  • Guatemala
      • Guatemala, Guatemala
        • Pfizer Investigational Site
  • India
    • Andhera Pradesh
      • Hyderabad, Andhera Pradesh, India, 500 063
        • Pfizer Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 060
        • Pfizer Investigational Site
      • Surat, Gujarat, India, 395 007
        • Pfizer Investigational Site
      • Vadodara, Gujarat, India, 390 015
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 030
        • Pfizer Investigational Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641 014
        • Pfizer Investigational Site
      • Madurai, Tamil Nadu, India, 625 107
        • Pfizer Investigational Site
  • Malaysia
    • Penang
      • Georgetown, Penang, Malaysia, 10990
        • Pfizer Investigational Site
  • Mexico
    • DF
      • Mexico, DF, Mexico, 14000
        • Pfizer Investigational Site
      • Mexico, DF, Mexico, 14080
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64718
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 13
        • Pfizer Investigational Site
      • Lima, Peru, 32
        • Pfizer Investigational Site
  • Philippines
      • Quezon City, Philippines, 1100
        • Pfizer Investigational Site
  • Romania
      • Cluj Napoca, Romania, 400 001
        • Pfizer Investigational Site
      • Iasi, Romania, 700 503
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 105077
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 121552
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 194156
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 197022
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 197341
        • Pfizer Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11159
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 83348
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2193
        • Pfizer Investigational Site
      • Stellenbosch, South Africa, 7600
        • Pfizer Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7531
        • Pfizer Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Pfizer Investigational Site
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Pfizer Investigational Site
  • Turkey
      • Istanbul, Fatih, Turkey, 34080
        • Pfizer Investigational Site
  • Ukraine
      • Kyiv, Ukraine, 03680
        • Pfizer Investigational Site
      • Kyiv, Ukraine
        • Pfizer Investigational Site
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Mather, California, United States, 95655
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Pfizer Investigational Site
      • Littleton, Colorado, United States, 80120
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34233
        • Pfizer Investigational Site
      • Weston, Florida, United States, 33331
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Pfizer Investigational Site
    • Maryland
      • Towson, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Pfizer Investigational Site
    • New York
      • Islandia, New York, United States, 11749
        • Pfizer Investigational Site
      • Stony Brook, New York, United States, 11794
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Pfizer Investigational Site
      • Lancaster, Pennsylvania, United States, 17603
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23225
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Sitaxsentan Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline/Day 1 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Weeks 4, 8 and 12 or Early Termination (ET)
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.
Baseline, Weeks 4, 8 and 12 or ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1321001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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