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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

This study has been terminated.
(Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00796666
First received: November 20, 2008
Last updated: March 6, 2012
Last verified: May 2011
History of Changes

November 20, 2008
March 6, 2012
May 2009
March 2011   (final data collection date for primary outcome measure)
Time to Clinical Worsening (TTCW) [ Time Frame: Baseline, Weeks 12, 24 or Early Termination (ET) ] [ Designated as safety issue: Yes ]
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.
The primary objective is to evaluate the efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy by determining time to clinical worsening in the treatment of subjects with PAH who have completed Study B1321001. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00796666 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) [ Time Frame: Baseline to Weeks 12 and 24 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
The secondary objective is to evaluate the safety and efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy who have completed Study B1321001 by change in 6-Minute Walk Distance, WHO functional class, and SF-36 Health Survey. [ Time Frame: Baseline/Day 1 to Weeks 12, 24, and 48 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
  • Drug: Sitaxsentan and Sildenafil
    Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
  • Experimental: Sitaxsentan and Placebo
    Monotherapy arm
    Intervention: Drug: Sitaxsentan
  • Experimental: Sitaxsentan and Sildenafil
    Combination treatment
    Intervention: Drug: Sitaxsentan and Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
131
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Chile,   China,   Colombia,   Czech Republic,   India,   Malaysia,   Mexico,   Peru,   Romania,   Russian Federation,   Serbia,   South Africa,   Thailand,   Turkey,   Ukraine
 
NCT00796666
B1321003
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP