A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
NCT00811018
Last updated date
ABOUT THIS STUDY
This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily
by subjects with PAH until sitaxsentan, in a particular country or region, is commercially
available for the treatment of PAH or the study is closed.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
12-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
- Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Has portal hypertension or chronic liver disease.
- Has history of left sided heart disease or significant cardiac disease.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension | |||
| Official Title ICMJE | A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension | |||
| Brief Summary | This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed. | |||
| Detailed Description | Open-label extension | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
| Condition ICMJE | Pulmonary Arterial Hypertension | |||
| Intervention ICMJE | Drug: Sitaxsentan
Sitaxsentan 100 mg tablets once daily Other Name: Sitaxentan | |||
| Study Arms ICMJE | Experimental: Sitaxsentan
Sitaxsentan Intervention: Drug: Sitaxsentan | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 1192 | |||
| Original Actual Enrollment ICMJE | 1208 | |||
| Actual Study Completion Date ICMJE | July 2011 | |||
| Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 12 Years to 75 Years (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00811018 | |||
| Other Study ID Numbers ICMJE | B1321007 FPH03 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||