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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00768300
First received: October 7, 2008
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: July 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
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
Participants were enrolled in a total of 136 study sites in North and South America, Europe, and Australia. The first participant was screened on 10 December 2008. The last participant observation was on 28 February 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
494 participants were randomized; 492 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups
  Description
Ambrisentan Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo Placebo to match ambrisentan administered orally once daily

Participant Flow:   Overall Study
    Ambrisentan   Placebo
STARTED   330   164 
Randomized and Treated   329   163 
COMPLETED   1   1 
NOT COMPLETED   329   163 
Randomized but not treated                1                1 
Adverse Event                10                2 
Protocol Violation                6                1 
Withdrawal by Subject                13                7 
Physician Decision                2                3 
Study discontinued by Sponsor                271                140 
Death                21                5 
Subject moved to pursue lung transplant                1                1 
Screen failure following randomization                1                0 
Received lung transplant                1                1 
Lost to Follow-up                0                1 
Began prohibited concomitant medication                0                1 
Treated but never dosed with Study drug                1                0 
Missing data                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 treated

Reporting Groups
  Description
Ambrisentan Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo Placebo to match ambrisentan administered orally once daily
Total Total of all reporting groups

Baseline Measures
   Ambrisentan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 329   163   492 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.8  (7.4)   66.1  (7.1)   65.9  (7.3) 
Gender 
[Units: Participants]
     
Female   85   52   137 
Male   244   111   355 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black or African Heritage   1   0   1 
White   293   145   438 
Asian   4   1   5 
American Indian or Alaskan Native   1   1   2 
Other   27   16   43 
Not Permitted   3   0   3 
Region of Enrollment [1] 
[Units: Participants]
     
United States   141   62   203 
Canada   25   14   39 
Australia   22   12   34 
France   21   10   31 
Germany   17   9   26 
Brazil   18   6   24 
Peru   12   6   18 
Czech Republic   10   6   16 
Israel   8   7   15 
Italy   11   3   14 
Belgium   7   6   13 
Colombia   8   3   11 
Mexico   5   4   9 
United Kingdom   3   6   9 
Spain   7   1   8 
Poland   3   3   6 
Switzerland   5   1   6 
Austria   2   2   4 
Chile   3   1   4 
Argentina   1   2   3 
Ireland   1   0   1 
[1] All participants who were randomized are presented in Region of Enrollment (ambrisentan = 330; placebo = 164)
Baseline Pulmonary Hypertension (PH) per interactive voice response system (IVRS) 
[Units: Participants]
     
No   293   145   438 
Yes   36   18   54 
Smoking status [1] 
[Units: Participants]
     
Never   105   53   158 
Current   7   5   12 
Former   217   104   321 
[1] Smoking status data is missing for one participant randomized to placebo.
Surgical lung biopsy (SLB) to Confirm Diagnosis of IPF (per IVRS) 
[Units: Participants]
     
No   175   87   262 
Yes   154   76   230 
Disease duration 
[Units: Years]
Mean (Standard Deviation)
 1.13  (1.39)   0.91  (1.19)   1.06  (1.33) 
Forced vital capacity (FVC) percent predicted 
[Units: Percentage of FVC % predicted]
Least Squares Mean (Standard Deviation)
 68.74  (13.12)   69.86  (13.75)   69.11  (13.33) 
Six mile walk test (6MWT) 
[Units: Meters]
Mean (Standard Deviation)
 410.4  (118.7)   420.5  (121.4)   413.7  (119.6) 
Hemoglobin Adjusted Diffusing lung capacity for carbon monoxide (DLCO) percent predicted 
[Units: Percentage of DLCO % predicted]
Least Squares Mean (Standard Deviation)
 42.04  (13.77)   45.57  (13.25)   43.20  (13.69) 
Prior IPF Medications [1] 
[Units: Participants]
     
No   205   97   302 
Yes   124   65   189 
[1] Prior IPF Medications data is missing for one participant randomized to placebo.
N-acetylcysteine (NAC) Use [1] 
[Units: Participants]
     
No   310   153   463 
Yes   19   8   27 
[1] NAC is a therapy commonly used in the treatment of IPF. NAC use data is missing for two participants randomized to placebo.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Death or Disease (IPF) Progression.   [ Time Frame: Up to 48 months ]

2.  Secondary:   Proportion of Participants With No Disease Progression or Death at 48 Weeks   [ Time Frame: Baseline and Week 48 ]

3.  Secondary:   Change in FVC % Predicted at Week 48   [ Time Frame: Baseline and Week 48 ]

4.  Secondary:   Change in DLCO % Predicted at Week 48   [ Time Frame: Baseline and Week 48 ]

5.  Secondary:   Change in 6MWT at Week 48   [ Time Frame: Baseline and Week 48 ]

6.  Secondary:   Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)   [ Time Frame: Baseline and Week 48 ]

7.  Secondary:   Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George’s Respiratory Questionnaire (SGRQ)   [ Time Frame: Baseline and Week 48 ]

8.  Secondary:   Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)   [ Time Frame: Baseline and Week 48 ]

9.  Secondary:   Percentage of Participants Who Developed PH on Study   [ Time Frame: Up to 48 weeks ]


  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
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  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


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00768300     History of Changes
Other Study ID Numbers: GS-US-231-0101
Study First Received: October 7, 2008
Results First Received: July 15, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration