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

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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