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Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitaxsentan and Placebo | Experimental | Monotherapy arm |
|
| Sitaxsentan and Sildenafil | Experimental | Combination treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitaxsentan | Drug | Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Fountain Valley | California | 92708 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants who successfully completed treatment in study B1321001 (NCT00795639).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitaxsentan and Placebo | Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID) |
| FG001 | Sitaxsentan and Sildenafil | Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sitaxsentan and Sildenafil | Drug | Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Pfizer Investigational Site | Weston | Florida | 33331 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02111 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Providence | Rhode Island | 02903 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53215 | United States |
| Pfizer Investigational Site | Buenos Aires | C1039AAO | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1428DCO | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1428DUS | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1431FWO | Argentina |
| Pfizer Investigational Site | Sofia | 1233 | Bulgaria |
| Pfizer Investigational Site | Temuco | 4781173 | Chile |
| Pfizer Investigational Site | Changsha | Hunan | 410008 | China |
| Pfizer Investigational Site | Beijing | 100032 | China |
| Pfizer Investigational Site | Shanghai | 200001 | China |
| Pfizer Investigational Site | Shanghai | 200433 | China |
| Pfizer Investigational Site | Bogotá | Cundinamarca | Colombia |
| Pfizer Investigational Site | Prague | 128 08 | Czechia |
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 001 | India |
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 063 | India |
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380 015 | India |
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380 060 | India |
| Pfizer Investigational Site | Surat | Gujarat | 395 007 | India |
| Pfizer Investigational Site | Vadodara | Gujarat | 390 015 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 030 | India |
| Pfizer Investigational Site | Coimbatore | Tamil Nadu | 641 014 | India |
| Pfizer Investigational Site | Madurai | Tamil Nadu | 625 107 | India |
| Pfizer Investigational Site | George Town | Pulau Pinang | 10990 | Malaysia |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64718 | Mexico |
| Pfizer Investigational Site | Lima | 32 | Peru |
| Pfizer Investigational Site | Cluj-Napoca | Romania | 400 001 | Romania |
| Pfizer Investigational Site | Iași | 700 503 | Romania |
| Pfizer Investigational Site | Moscow | 105077 | Russia |
| Pfizer Investigational Site | Moscow | 194156 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 197022 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 197341 | Russia |
| Pfizer Investigational Site | Belgrade | 11000 | Serbia |
| Pfizer Investigational Site | Johannesburg | 2193 | South Africa |
| Pfizer Investigational Site | Bangkoknoi | Bangkok | 10700 | Thailand |
| Pfizer Investigational Site | Istanbul, Fatih | 34080 | Turkey (Türkiye) |
| Pfizer Investigational Site | Kyiv | 03680 | Ukraine |
| Pfizer Investigational Site | Kyiv | Ukraine |
| Treated |
|
| Randomized and Not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitaxsentan and Placebo | Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID) |
| BG001 | Sitaxsentan and Sildenafil | Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| World Health Organization (WHO) Functional Classification | WHO Pulmonary Atrial Hypertension (PAH) Functional Classification: I (no limitation on physical activity), II (slight limitation on ordinary physical activity), III (marked limitations on physical activity comfortable at rest) and IV (unable to carry out any physical activity without symptoms, dyspnea and fatigue present at rest). | Number | number |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-Treat population (ITT): all participants who were randomized | Posted | Median | Full Range | Days | Baseline, Weeks 12, 24 or Early Termination (ET) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method | Posted | Mean | Standard Deviation | meters (m) | Baseline to Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT | Posted | Number | participant | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 and ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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| 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. | ITT; N=number of participants analyzed | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24 or ET |
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Not provided
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitaxsentan and Placebo | Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID) | 14 | 66 | 26 | 66 | ||
| EG001 | Sitaxsentan and Sildenafil | Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID | 15 | 64 | 28 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Venous pressure jugular increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
Study terminated early by sponsor, no Week 48 information collected.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C106276 | sitaxsentan |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 45-64 years |
|
| >= 65 years |
|
| Male |
|
| Functional Class II |
|
| Functional Class III |
|
| Functional Class IV |
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