Trial · NCT00879229

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

NCT00879229, Phase 3, Terminated, Gilead Sciences; results first posted 2014-04-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis. Trials, record NCT00879229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00879229

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
NCT number: NCT00879229
Status: Terminated
Phases: Phase 3
Enrollment: 40 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
Interventions: Ambrisentan, Placebo
First posted: 2009-04-09
Last updated: 2014-05-15
Results first posted: 2014-04-22
Limitations and caveats: Study GS-US-300-0128 was terminated early with enrollment of 40 of 225 planned subjects.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Six-minute Walk Distance (6MWD).	Baseline to Week 16	The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.
Secondary	Long-term Survival	Week 48	Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.
Secondary	Transition Dyspnea Index (TDI)	Baseline to Week 16	The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic "Baseline Dyspnea Index." The TDI range is -9 to +9 (worst to best; 0 = no change).
Secondary	Change From Baseline in WHO Functional Class	Baseline to Week 16	WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase ("+1: Improved"), decrease ("-1: Deteriorated"), or no change ("0: No change") on the scale.
Secondary	Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted	Baseline to Week 16	FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.
Secondary	Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)	Baseline to Week 16	Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.
Secondary	Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise	Baseline to Week 16	Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).
Secondary	Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted	Baseline to Week 16	DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.
Secondary	Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)	Baseline to Week 16	Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.
Secondary	Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)	Baseline to Week 16	The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Six-minute Walk Distance (6MWD).	Baseline to Week 16	Participants in the Full Analysis Set (randomized and received at least one dose of study medication) with evaluable data were analyzed.	meters	MEAN
SECONDARY	Long-term Survival	Week 48	Full Analysis Set	percent probability (KM% estimate)	NUMBER
SECONDARY	Transition Dyspnea Index (TDI)	Baseline to Week 16	Participants in the Full Analysis Set with evaluable data were analyzed.	units on a scale	MEAN
SECONDARY	Change From Baseline in WHO Functional Class	Baseline to Week 16	Participants in the Full Analysis Set with evaluable data were analyzed.	units on a scale	NUMBER
SECONDARY	Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted	Baseline to Week 16	Insufficient data due to study termination
SECONDARY	Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)	Baseline to Week 16	Insufficient data due to study termination
SECONDARY	Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise	Baseline to Week 16	Insufficient data due to study termination
SECONDARY	Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted	Baseline to Week 16	Insufficient data due to study termination
SECONDARY	Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)	Baseline to Week 16	Insufficient data due to study termination
SECONDARY	Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)	Baseline to Week 16	Insufficient data due to study termination

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Six-minute Walk Distance (6MWD).	Ambrisentan		-96	Standard Error 38	meters
Change From Baseline in Six-minute Walk Distance (6MWD).	Placebo		-67	Standard Error 51	meters
Long-term Survival	Ambrisentan		22	95% Confidence Interval 2.6 to 41.0	percent probability (KM% estimate)
Long-term Survival	Placebo		23	95% Confidence Interval 0.0 to 52.5	percent probability (KM% estimate)
Transition Dyspnea Index (TDI)	Ambrisentan		-1.5	Standard Deviation 3.08	units on a scale
Transition Dyspnea Index (TDI)	Placebo		-1.4	Standard Deviation 3.78	units on a scale
Change From Baseline in WHO Functional Class	Ambrisentan	-1: Deteriorated	0		units on a scale
Change From Baseline in WHO Functional Class	Placebo	-1: Deteriorated	1		units on a scale
Change From Baseline in WHO Functional Class	Ambrisentan	0: No change	11		units on a scale
Change From Baseline in WHO Functional Class	Placebo	0: No change	5		units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ambrisentan	25
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Ambrisentan	3
Overall Study	COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Ambrisentan	22
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events154

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
other	Constipation	Gastrointestinal disorders	Ambrisentan	4	25
other	Constipation	Gastrointestinal disorders	Placebo	1	15
other	Abdominal distension	Gastrointestinal disorders	Ambrisentan	2	25
other	Abdominal distension	Gastrointestinal disorders	Placebo	0	15
other	Abdominal pain upper	Gastrointestinal disorders	Ambrisentan	1	25
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	15
other	Abdominal discomfort	Gastrointestinal disorders	Ambrisentan	0	25
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	1	15
other	Abdominal pain	Gastrointestinal disorders	Ambrisentan	0	25
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	15

1 to 10 of 154Source ClinicalTrials.gov

See all 154 adverse events

Adverse 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	18	25
Total, other adverse events	Placebo	12	15
Total, serious adverse events	Ambrisentan	12	25
Total, serious adverse events	Placebo	3	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25613108	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00879229

GET https://conductscience.org/api/trials/v1/NCT00879229/events?page=2

API reference For AI assistants