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drugset / Trial / NCT01204853

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

NCT01204853 ↗

Phase 3 Terminated 2 enrolled Pfizer
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2010-11
Completion
2010-11

Outcome

Outcome not reported

Stopped: “Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitaxentan Small molecule 100 mg Oral

Indications

pulmonary arterial hypertension