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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

October 7, 2008
December 24, 2010
December 2008
December 2010   (final data collection date for primary outcome measure)
Time to death or disease (IPF) progression. [ Time Frame: Event driven, up to 4 years ] [ Designated as safety issue: No ]
Time to death or disease (IPF) progression. [ Time Frame: Event driven, up to 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00768300 on ClinicalTrials.gov Archive Site
Proportion of subjects with disease progression or death at 48 weeks [ Time Frame: 1 year from enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
(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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
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.
  • Active Comparator: 1 Ambrisentan
    Subjects will be randomized in a 2:1 ratio to receive Ambrisentan
    Intervention: Drug: ambrisentan or sugar pill
  • Placebo Comparator: 2 Placebo
    Subjects will be randomized in a 2:1 ratio to receive active drug versus sugar pill (placebo.
    Intervention: Drug: ambrisentan or sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
660
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   France,   Germany,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00768300
GS-US-231-0101
Yes
Thomas O'Riordan, MD, GSI
Gilead Sciences
Not Provided
Study Chair: Ganesh Raghu, MD University of Washington, Div. of Pulmonary and Critical Care Medicine Chair
Gilead Sciences
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP