A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension (ARTEMIS-PH)

NCT00879229 Phase 3 TERMINATED Results posted

Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

Details

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	TERMINATED
Enrolment	40
Start date	2009-07
Completion	2011-02

Conditions

• Idiopathic Pulmonary Fibrosis
• Pulmonary Hypertension

Interventions

• Ambrisentan
• Placebo

Primary outcomes

• Change From Baseline in Six-minute Walk Distance (6MWD). — Baseline to Week 16
  The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.

Countries

United States, Australia, Austria, Canada, Germany, Italy, United Kingdom