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

This study has been terminated.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00768300
First received: October 7, 2008
Last updated: December 24, 2010
Last verified: December 2010
History of Changes
  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.


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

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

Resource links provided by NLM:

Drug Information available for: Ambrisentan
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Time to death or disease (IPF) progression. [ Time Frame: Event driven, up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with disease progression or death at 48 weeks [ Time Frame: 1 year from enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Ambrisentan
Subjects will be randomized in a 2:1 ratio to receive Ambrisentan
 Drug: ambrisentan or sugar pill
Ambrisentan 5mg or 10 mg tablet, or sugar pill (placebo) taken once a day, by mouth for the duration of the trial.
Placebo Comparator: 2 Placebo
Subjects will be randomized in a 2:1 ratio to receive active drug versus sugar pill (placebo.
 Drug: ambrisentan or sugar pill
Ambrisentan 5mg or 10 mg tablet, or sugar pill (placebo) taken once a day, by mouth for the duration of the trial.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of IPF
  • Honeycombing on HRCT scan of less than or equal to 5%
  • Willing and able to have 2 right heart catheterizations performed
  • Willing to have monthly lab tests
  • Able to perform the 6 minute walk test
  • Must meet lung function requirements
  • Normal liver function tests

Exclusion Criteria:

  • No restrictive lung disease (other than IPF)
  • No obstructive lung disease
  • No recent or active respiratory exacerbations
  • No recent hospitalization for an IPF exacerbation
  • No recent history of alcohol abuse
  • Not pregnant, breast-feeding and willing to follow contraceptive measures per protocol if applicable
  • Chronic sildenafil (or same drug class) use for pulmonary hypertension
  • Chronic treatment with certain medications for IPF within 30 days of randomization
  • No other serious medical conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768300

  Show 185 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Ganesh Raghu, MD University of Washington, Div. of Pulmonary and Critical Care Medicine Chair
  More Information

No publications provided

Responsible Party: Thomas O'Riordan, MD, GSI
ClinicalTrials.gov Identifier: NCT00768300     History of Changes
Other Study ID Numbers: GS-US-231-0101
Study First Received: October 7, 2008
Last Updated: December 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
idiopathic pulmonary fibrosis
interstitial lung disease
ambrisentan

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 16, 2013