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

NCT00768300 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2014-04-08

Study results available
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Summary

The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

Conditions

Interventions

DRUG

Ambrisentan

Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.

DRUG

Placebo

Placebo to match ambrisentan was administered orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Ganesh Raghu, MD · University of Washington, Div. of Pulmonary and Critical Care Medicine Chair

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00768300 on ClinicalTrials.gov