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(ARTEMIS-IPF)Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF


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




The ARTEMIS-IPF study is for people who have been diagnosed with IPF and are between 40-80 years of age. People who have been diagnosed early in the disease may be more responsive to treatment. This is a randomized study (which means the participants will be selected by chance (like flipping a coin) to receive one of two treatments (ambrisentan or placebo). This is a double-blind study which means participants and their study doctor won`t know what treatment they are assigned to receive. Participants will have 2 out of 3 chances to receive ambrisentan, or 1 out of 3 chances to receive placebo (which is a tablet that looks like the active medicine but contains no active medicine)Taking part in the study could be up to 4 years depending on how long it takes to enroll and observe study events. After randomization, visits take place every 3 months. Laboratory visits occur every month.

Study Status: Terminated


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: ambrisentan or sugar pill Phase 3

Verified by Gilead Sciences December, 2010

Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences identifier: NCT00768300

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

The Cleveland Clinic Foundation
Cleveland, Ohio 44795
United States

Ganesh Raghu, MD., Study Chair

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