Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

March 4, 2015 updated by: Pfizer

A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

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
  • 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
  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Czech Republic
      • Praha 2, Czech Republic, 128 08
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Pfizer Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500 063
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 060
        • Pfizer Investigational Site
      • Ahmedabad, Gujarat, India, 380 015
        • 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
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64718
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 32
        • 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, 194156
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 197022
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 197341
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
  • South Africa
      • Johannesburg, South Africa, 2193
        • Pfizer Investigational Site
  • Thailand
    • 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
    • Florida
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Weston, Florida, United States, 33331
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • 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
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • 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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Exclusion Criteria:

  • Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sitaxsentan and Placebo
Monotherapy arm
Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
EXPERIMENTAL: Sitaxsentan and Sildenafil
Combination treatment
Drug: Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Worsening (TTCW)
Time Frame: Baseline, Weeks 12, 24 or Early Termination (ET)
Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study's first dose date in and date when first clinical worsening event occurs.
Baseline, Weeks 12, 24 or Early Termination (ET)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)
Time Frame: Baseline to Weeks 12 and 24
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 from baseline = score at Week x - score at baseline.
Baseline to Weeks 12 and 24
Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48
Time Frame: Baseline, Weeks 12, 24 or ET
WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain
Time Frame: Baseline, Weeks 12, 24 and ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.
Baseline, Weeks 12, 24 and ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health
Time Frame: Baseline, Weeks 12, 24 or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.
Baseline, Weeks 12, 24 or ET

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2009

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 24, 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

  • B1321003

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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