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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 sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitaxsentan | 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 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up. | Baseline and every 12 weeks up to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24 | The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline. | Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18) |
| Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH) |
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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 |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were previously enrolled in B1321001 (NCT00795639) or B1321003 (NCT00796666) only where pre-specified entry criteria were met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitaxsentan | Sitaxsentan 100 milligrams (mg) orally once a day |
| FG001 | Sitaxsentan and Sildenafil | Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day |
| 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 |
|
The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms). |
| Baseline, Week 12 and ET (up to Week 18) |
| Cluj-Napoca |
| 400 001 |
| Romania |
| Pfizer Investigational Site | Kyiv | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitaxsentan | Sitaxsentan 100 milligrams (mg) orally once a day |
| BG001 | Sitaxsentan and Sildenafil | Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day |
| 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, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Overall Survival | Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up. | Due to the premature termination only 3 participants were recruited into this study. No analyses were performed. | Posted | Baseline and every 12 weeks up to Week 18 |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24 | The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline. | Due to the premature termination only 3 participants were recruited into this study. No analyses were performed. | Posted | Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18) |
|
| ||||||||||||||||||||||
| Secondary | Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH) | The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms). | Due to the premature termination only 3 participants were recruited into this study. No analyses were performed. | Posted | Baseline, Week 12 and ET (up to Week 18) |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitaxsentan | Sitaxsentan 100 milligrams (mg) orally once a day | 1 | 3 | 1 | 3 | ||
| EG001 | Sitaxsentan and Sildenafil | Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Due to the premature termination only 3 participants were recruited into this study. No summarization or analysis was done.
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 |
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| 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 |
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