Pulmonary Hypertension Clinical Trial
Official title:
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)
Verified date | March 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Argentina, Bulgaria, Chile, China, Colombia, Czech Republic, India, Malaysia, Mexico, Peru, Romania, Russian Federation, Serbia, South Africa, Thailand, Turkey, Ukraine,
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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