Trial · NCT00768300
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
NCT00768300, Phase 3, Terminated, Gilead Sciences; results first posted 2014-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. (ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF. Trials, record NCT00768300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00768300
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- (ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
- NCT number
- NCT00768300
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 494 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Ambrisentan, Placebo
- First posted
- 2008-10-08
- Last updated
- 2014-04-08
- Results first posted
- 2014-04-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Death or Disease (IPF) Progression. | Up to 48 months | The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following: * Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days * Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan * All-cause mortality |
| Secondary | Proportion of Participants With No Disease Progression or Death at 48 Weeks | Baseline and Week 48 | The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression. |
| Secondary | Change in FVC % Predicted at Week 48 | Baseline and Week 48 | FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. |
| Secondary | Change in DLCO % Predicted at Week 48 | Baseline and Week 48 | DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition. |
| Secondary | Change in 6MWT at Week 48 | Baseline and Week 48 | The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. |
| Secondary | Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36) | Baseline and Week 48 | The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. |
| Secondary | Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ) | Baseline and Week 48 | The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations. |
| Secondary | Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI) | Baseline and Week 48 | The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests. |
| Secondary | Percentage of Participants Who Developed PH on Study | Up to 48 weeks | The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Death or Disease (IPF) Progression. | Up to 48 months | Full Analysis Set: participants who were randomized and treated | weeks | MEDIAN |
| SECONDARY | Proportion of Participants With No Disease Progression or Death at 48 Weeks | Baseline and Week 48 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Change in FVC % Predicted at Week 48 | Baseline and Week 48 | Participants in the Full Analysis Set with evaluable change data were analyzed. | percent change in FVC % predicted | MEAN |
| SECONDARY | Change in DLCO % Predicted at Week 48 | Baseline and Week 48 | Participants in the Full Analysis Set with evaluable change data were analyzed. | percent change in DLCO % predicted | MEAN |
| SECONDARY | Change in 6MWT at Week 48 | Baseline and Week 48 | Participants in the Full Analysis Set with evaluable change data were analyzed. | meters | MEAN |
| SECONDARY | Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36) | Baseline and Week 48 | Participants in the Full Analysis Set with evaluable change data were analyzed. | units on a scale | MEAN |
| SECONDARY | Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ) | Baseline and Week 48 | Participants in the Full Analysis Set with evaluable change data were analyzed. | units on a scale | MEAN |
| SECONDARY | Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI) | Baseline and Week 48 | Participants in the Full Analysis Set with evaluable change data were analyzed. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Developed PH on Study | Up to 48 weeks | Participants in the Full Analysis Set without PH at baseline were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Death or Disease (IPF) Progression. | Ambrisentan | 84.14 | Inter-Quartile Range 36.00 to NA | weeks | |
| Time to Death or Disease (IPF) Progression. | Placebo | NA | Inter-Quartile Range 60.00 to NA | weeks | |
| Proportion of Participants With No Disease Progression or Death at 48 Weeks | Ambrisentan | 65 | percentage of participants | ||
| Proportion of Participants With No Disease Progression or Death at 48 Weeks | Placebo | 80 | percentage of participants | ||
| Change in FVC % Predicted at Week 48 | Ambrisentan | -10.24 | Standard Deviation 25.95 | percent change in FVC % predicted | |
| Change in FVC % Predicted at Week 48 | Placebo | -5.28 | Standard Deviation 15.68 | percent change in FVC % predicted | |
| Change in DLCO % Predicted at Week 48 | Ambrisentan | -2.68 | Standard Deviation 27.60 | percent change in DLCO % predicted | |
| Change in DLCO % Predicted at Week 48 | Placebo | -11.28 | Standard Deviation 32.06 | percent change in DLCO % predicted | |
| Change in 6MWT at Week 48 | Ambrisentan | -52.5 | Standard Deviation 148.7 | meters | |
| Change in 6MWT at Week 48 | Placebo | -10.6 | Standard Deviation 89.8 | meters |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ambrisentan | 330 | |
| Overall Study | STARTED | Placebo | 164 | |
| Overall Study | Randomized and Treated | Ambrisentan | 329 | |
| Overall Study | Randomized and Treated | Placebo | 163 | |
| Overall Study | COMPLETED | Ambrisentan | 1 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 329 | |
| Overall Study | NOT COMPLETED | Placebo | 163 |
Source ClinicalTrials.gov
Adverse events296
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Ambrisentan | 73 | 329 | |
| other | Oedema peripheral | General disorders | Placebo | 14 | 163 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 47 | 329 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Placebo | 18 | 163 | |
| other | Headache | Nervous system disorders | Ambrisentan | 47 | 329 | |
| other | Headache | Nervous system disorders | Placebo | 17 | 163 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 40 | 329 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 11 | 163 | |
| other | Nasopharyngitis | Infections and infestations | Ambrisentan | 37 | 329 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 18 | 163 |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ambrisentan | 227 | 329 |
| Total, other adverse events | Placebo | 104 | 163 |
| Total, serious adverse events | Ambrisentan | 73 | 329 |
| Total, serious adverse events | Placebo | 25 | 163 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ambrisentan vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00768300
GET https://conductscience.org/api/trials/v1/NCT00768300/results?page=2