NCT01204853

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

A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Sitaxentan	sitaxentan sodium 100 mg

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-09-17
• Last updated: 2011-12-01
• Results posted: 2011-12-01

Locations

2 sites across 1 country: Japan