Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF - Full Text View

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00768300

Purpose

The ARTEMIS study is for people who have been diagnosed with IPF in the last 3 years 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 3 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 III

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Ambrisentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ARTEMIS: 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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Time to death or disease (IPF) progression. [ Time Frame: Event driven, up to 3 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:	600
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Ambrisentan: Active Comparator 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.
2 Placebo: Placebo Comparator 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 within 3 years
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

Contacts

Contact: Crystal Green

AMS-IPF@gilead.com

Show 73 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

Responsible Party:	GSI ( Brent Appleton, MD )
Study ID Numbers:	GS-US-231-0101
Study First Received:	October 7, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00768300
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

idiopathic pulmonary fibrosis
interstitial lung disease
ambrisentan

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis

Hamman-Rich syndrome
Lung Diseases
Pulmonary Fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009