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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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The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitaxentan treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitaxentan | Drug | sitaxentan sodium 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants with any adverse events, severe adverse events, serious adverse events | Up to 22 days (last participant discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Worsening | Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen. | Up to 22 days (last participant discontinuation) |
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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 | Nagoya | Aichi-ken | Japan | |||
| 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 received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks in preceding B1321052 study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitaxentan Treatment | All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitaxentan Treatment | All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Participants With Adverse Events | Number of participants with any adverse events, severe adverse events, serious adverse events | The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study. | Posted | Number | Participants | Up to 22 days (last participant discontinuation) |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject 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 | Sitaxentan Treatment | All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C106276 | sitaxsentan |
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| Change From Baseline in 6-Minute Walk Distance | Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline. | Up to 22 days (last participant discontinuation) |
| Percentage of Participants With Change From Baseline in WHO Functional Class | The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48). | Up to 22 days (last participant discontinuation) |
| Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline. | Up to 22 days (last participant discontinuation) |
| Shinjyuku-ku |
| Tokyo |
| Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Participants With Clinical Worsening | Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen. | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Posted | Number | Percentage of participants | Up to 22 days (last participant discontinuation) |
|
|
| Secondary | Change From Baseline in 6-Minute Walk Distance | Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline. | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Posted | Mean | Standard Deviation | Meters | Up to 22 days (last participant discontinuation) |
|
|
| Secondary | Percentage of Participants With Change From Baseline in WHO Functional Class | The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48). | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Posted | Number | Parcentage of participants | Up to 22 days (last participant discontinuation) |
|
|
| Secondary | Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline. | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Posted | Mean | Standard Deviation | pg/mL | Up to 22 days (last participant discontinuation) |
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| D002318 |
| Cardiovascular Diseases |