Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
NCT01210443
Last updated date
ABOUT THIS STUDY
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.
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.
Hypertension, Pulmonary
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
16-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Subject who completed the B1321052 study as planned.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
>160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.
- Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5
minutes at Screening.
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Hypertension, PulmonaryLong-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
NCT01210443
- Nagoya, Aichi
- Shinjyuku-ku, Tokyo
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | |||
| Official Title ICMJE | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Hypertension, Pulmonary | |||
| Intervention ICMJE | Drug: Sitaxentan
sitaxentan sodium 100 mg | |||
| Study Arms ICMJE | Experimental: Sitaxentan treatment
Intervention: Drug: Sitaxentan | |||
| 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 | 2 | |||
| Original Estimated Enrollment ICMJE | 32 | |||
| Actual Study Completion Date ICMJE | December 2010 | |||
| Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 16 Years to 80 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 | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01210443 | |||
| Other Study ID Numbers ICMJE | B1321053 | |||
| Has Data Monitoring Committee | Yes | |||
| 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 | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||