Study:
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)
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| 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
ClinicalTrials.gov 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