A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: Sitaxentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204853

B1321052

Details and patient eligibility

About

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 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.

Enrollment: 2 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a current diagnosis of symptomatic PAH
• Has 6MWT distances from 150 to 450 meters and distance

Exclusion criteria

• Previous exposure to an endothelin receptor antagonist
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Sitaxentan treatment

Experimental group

Treatment:

Drug: Sitaxentan