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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00796666
Other study ID # B1321003
Secondary ID
Status Terminated
Phase Phase 3
First received November 20, 2008
Last updated March 4, 2015
Start date May 2009
Est. completion date March 2011

Study information

Verified date March 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 131
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Locations

Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Bulgaria Pfizer Investigational Site Sofia
Chile Pfizer Investigational Site Temuco
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Changsha Hunan
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
Colombia Pfizer Investigational Site Bogotá Cundinamarca
Czech Republic Pfizer Investigational Site Praha 2
India Pfizer Investigational Site Ahmedabad Gujarat
India Pfizer Investigational Site Ahmedabad Gujarat
India Pfizer Investigational Site Coimbatore Tamil Nadu
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Madurai Tamil Nadu
India Pfizer Investigational Site Pune Maharashtra
India Pfizer Investigational Site Surat Gujarat
India Pfizer Investigational Site Vadodara Gujarat
Malaysia Pfizer Investigational Site Georgetown Penang
Mexico Pfizer Investigational Site Monterrey Nuevo Leon
Peru Pfizer Investigational Site Lima
Romania Pfizer Investigational Site Cluj Napoca
Romania Pfizer Investigational Site Iasi
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Saint-Petersburg
Russian Federation Pfizer Investigational Site Saint-Petersburg
Serbia Pfizer Investigational Site Belgrade
South Africa Pfizer Investigational Site Johannesburg
Thailand Pfizer Investigational Site Bangkoknoi Bangkok
Turkey Pfizer Investigational Site Istanbul, Fatih
Ukraine Pfizer Investigational Site Kyiv
Ukraine Pfizer Investigational Site Kyiv
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Chile,  China,  Colombia,  Czech Republic,  India,  Malaysia,  Mexico,  Peru,  Romania,  Russian Federation,  Serbia,  South Africa,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Clinical Worsening (TTCW) 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) Yes
Secondary Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) 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 Yes
Secondary Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain 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 Yes
Secondary 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 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain 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 Yes
Secondary 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 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health 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 Yes
Secondary Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health 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 Yes
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