Status:
TERMINATED
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Lead Sponsor:
Pfizer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
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. ...
Eligibility Criteria
Inclusion
- Subject who completed the B1321052 study as planned.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01210443
Start Date
November 1 2010
End Date
December 1 2010
Last Update
December 14 2011
Active Locations (2)
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1
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
2
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan