ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00879229
First received: April 8, 2009
Last updated: May 5, 2014
Last verified: May 2014
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Idiopathic Pulmonary Fibrosis
Pulmonary Hypertension
Interventions: Drug: Ambrisentan
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in a total of 29 study sites in Australia, Europe, and North America. The first participant was screened on 21 October 2009. The last participant observation was on 22 February 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
96 participants were screened; 40 participants were randomized and treated, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups
  Description
Ambrisentan Participants were randomized to receive ambrisentan treatment for 56 weeks
Placebo Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.

Participant Flow:   Overall Study
    Ambrisentan     Placebo  
STARTED     25     15  
COMPLETED     3     1  
NOT COMPLETED     22     14  
Study terminated by Sponsor                 13                 12  
Death                 4                 2  
Adverse Event                 2                 0  
Withdrawal by Subject                 1                 0  
Clinical status did not improve                 1                 0  
Unknown                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set: participants who were randomized and received at least one dose of study drug

Reporting Groups
  Description
Ambrisentan Participants were randomized to receive ambrisentan treatment for 56 weeks
Placebo Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Ambrisentan     Placebo     Total  
Number of Participants  
[units: participants]
  25     15     40  
Age  
[units: years]
Mean ± Standard Deviation
  68  ± 7.7     68  ± 5.2     68  ± 6.8  
Gender  
[units: participants]
     
Female     5     5     10  
Male     20     10     30  
Race/Ethnicity, Customized  
[units: participants]
     
White     25     14     39  
Asian     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     14     9     23  
Australia     3     2     5  
Italy     4     1     5  
Canada     3     1     4  
Germany     1     2     3  
Baseline Dyspnea Index (BDI) [1]
[units: units on a scale]
Mean ± Standard Deviation
  5.0  ± 2.15     4.4  ± 2.10     4.8  ± 2.13  
[1] BDI range is 0 to 12 (worst to best).



  Outcome Measures
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1.  Primary:   Change From Baseline in Six-minute Walk Distance (6MWD).   [ Time Frame: Baseline to Week 16 ]

2.  Secondary:   Long-term Survival   [ Time Frame: Week 48 ]

3.  Secondary:   Transition Dyspnea Index (TDI)   [ Time Frame: Baseline to Week 16 ]

4.  Secondary:   Change From Baseline in WHO Functional Class   [ Time Frame: Baseline to Week 16 ]

5.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted   [ Time Frame: Baseline to Week 16 ]

6.  Secondary:   Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)   [ Time Frame: Baseline to Week 16 ]

7.  Secondary:   Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise   [ Time Frame: Baseline to Week 16 ]

8.  Secondary:   Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted   [ Time Frame: Baseline to Week 16 ]

9.  Secondary:   Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)   [ Time Frame: Baseline to Week 16 ]

10.  Secondary:   Change in QOL Score as Assessed by the St. George’s Respiratory Questionnaire (SRGQ)   [ Time Frame: Baseline to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study GS-US-300-0128 was terminated early with enrollment of 40 of 225 planned subjects.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00879229     History of Changes
Other Study ID Numbers: GS-US-300-0128
Study First Received: April 8, 2009
Results First Received: August 9, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration