Trial · NCT00578786

A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

NCT00578786, Phase 3, Completed, Gilead Sciences; results first posted 2013-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202). Trials, record NCT00578786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578786

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Trial

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

Title: A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
NCT number: NCT00578786
Status: Completed
Phases: Phase 3
Enrollment: 383 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Pulmonary Arterial Hypertension
Interventions: ambrisentan
First posted: 2007-12-21
Last updated: 2013-01-15
Results first posted: 2013-01-15
Limitations and caveats: Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. At Year 3, almost half of those randomized to 2.5 mg were titrated to 5 mg and 10 mg; a third starting at 5 mg were titrated to 10 mg.

Source ClinicalTrials.gov

Registered outcomes22

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

List	Outcome	Time frame	Description
Primary	Frequently Reported (15% or More Overall) Adverse Events by Severity	Baseline to Week 295	The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to AMB in participants with PAH. The most frequently occurring adverse events (occurring in 15% or more of the participants in the combined group) are presented, by severity, that began after entering this extension study. Adverse events that were serious are included. Adverse events are coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 6.1 and are presented by MedDRA preferred term. Severity was graded as follows: mild (AE did not interfere with routine activities; subject may have experienced slight discomfort), moderate (AE interfered with routine activities; subject may have experienced significant discomfort), and severe (AE made it impossible to perform routine activities; subject may have experienced intolerable discomfort or pain).
Primary	Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)	Baseline to Week 295	The number of participants with serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) falling into the following categories: \>3.0 and \</= 5.0 x ULN, \>5.0 and \</= 8.0 x ULN, and \>8.0 x ULN. Includes the highest value per participant across all visits as well as values from early termination visits.
Secondary	Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline	The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.).
Secondary	Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Week 24	The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). Missing values were imputed using LOCF method based on post-baseline observations. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.
Secondary	Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Week 48	The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.
Secondary	Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Year 2	The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.
Secondary	Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Year 3	Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.
Secondary	Baseline Borg Dyspnea Index	Baseline	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	Change From Baseline to Year 1 in Borg Dyspnea Index	Baseline to Year 1	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). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.
Secondary	Change From Baseline to Year 2 in Borg Dyspnea Index	Baseline to Year 2	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). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	Meters	MEAN
PRIMARY	Frequently Reported (15% or More Overall) Adverse Events by Severity	Baseline to Week 295	Safety Analysis Set: Includes all participants who received at least 1 dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Treatment group assignments for the safety analysis set were based upon the highest dose of AMB received at any time during the parent or extension studies.	participants	NUMBER
SECONDARY	Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Week 24	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	Meters	MEAN
SECONDARY	Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Week 48	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	Meters	MEAN
SECONDARY	Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Year 2	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	Meters	MEAN
SECONDARY	Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Baseline to Year 3	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	Meters	MEAN
SECONDARY	Baseline Borg Dyspnea Index	Baseline	All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.	units on a scale	MEAN
SECONDARY	Change From Baseline to Year 1 in Borg Dyspnea Index	Baseline to Year 1	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	units on a scale	MEAN
SECONDARY	Change From Baseline to Year 2 in Borg Dyspnea Index	Baseline to Year 2	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	units on a scale	MEAN
SECONDARY	Change From Baseline to Year 3 in Borg Dyspnea Index	Baseline to Year 3	All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.	units on a scale	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group307

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

Outcome	Group	Category	Value	Spread	Units
Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Ambrisentan 2.5 mg		350.3	Standard Deviation 86.64	Meters
Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Ambrisentan 5 mg		347.7	Standard Deviation 87.33	Meters
Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Ambrisentan 10 mg		342.3	Standard Deviation 80.84	Meters
Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test	Combined Ambrisentan Group		347.0	Standard Deviation 85.39	Meters
Frequently Reported (15% or More Overall) Adverse Events by Severity	Ambrisentan 2.5 mg	Headache - Mild	1		participants
Frequently Reported (15% or More Overall) Adverse Events by Severity	Ambrisentan 5 mg	Headache - Mild	20		participants
Frequently Reported (15% or More Overall) Adverse Events by Severity	Ambrisentan 10 mg	Headache - Mild	36		participants
Frequently Reported (15% or More Overall) Adverse Events by Severity	Ambrisentan 2.5 mg	Headache - Moderate	0		participants
Frequently Reported (15% or More Overall) Adverse Events by Severity	Ambrisentan 5 mg	Headache - Moderate	14		participants
Frequently Reported (15% or More Overall) Adverse Events by Severity	Ambrisentan 10 mg	Headache - Moderate	17		participants

1 to 10 of 307Source ClinicalTrials.gov

See all 307 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ambrisentan 2.5 mg	96
Overall Study	STARTED	Ambrisentan 5 mg	190
Overall Study	STARTED	Ambrisentan 10 mg	97
Overall Study	COMPLETED	Ambrisentan 2.5 mg	57
Overall Study	COMPLETED	Ambrisentan 5 mg	124
Overall Study	COMPLETED	Ambrisentan 10 mg	67
Overall Study	NOT COMPLETED	Ambrisentan 2.5 mg	39
Overall Study	NOT COMPLETED	Ambrisentan 5 mg	66
Overall Study	NOT COMPLETED	Ambrisentan 10 mg	30

Source ClinicalTrials.gov

Adverse events852

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	Abdominal distension	Gastrointestinal disorders	Ambrisentan 2.5 mg	0	43
other	Abdominal distension	Gastrointestinal disorders	Ambrisentan 5 mg	2	146
other	Abdominal distension	Gastrointestinal disorders	Ambrisentan 10 mg	15	194
other	Abdominal pain	Gastrointestinal disorders	Ambrisentan 2.5 mg	2	43
other	Abdominal pain	Gastrointestinal disorders	Ambrisentan 5 mg	11	146
other	Abdominal pain	Gastrointestinal disorders	Ambrisentan 10 mg	16	194
other	Abdominal pain upper	Gastrointestinal disorders	Ambrisentan 2.5 mg	2	43
other	Abdominal pain upper	Gastrointestinal disorders	Ambrisentan 5 mg	6	146
other	Abdominal pain upper	Gastrointestinal disorders	Ambrisentan 10 mg	21	194
other	Abnormal chest sound	Respiratory, thoracic and mediastinal disorders	Ambrisentan 2.5 mg	0	43

1 to 10 of 852Source ClinicalTrials.gov

See all 852 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ambrisentan 2.5 mg
Total, all-cause mortality	Ambrisentan 5 mg
Total, all-cause mortality	Ambrisentan 10 mg
Total, other adverse events	Ambrisentan 2.5 mg	36	43
Total, other adverse events	Ambrisentan 5 mg	131	146
Total, other adverse events	Ambrisentan 10 mg	190	194
Total, serious adverse events	Ambrisentan 2.5 mg	26	43
Total, serious adverse events	Ambrisentan 5 mg	76	146
Total, serious adverse events	Ambrisentan 10 mg	103	194

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19909879	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

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GET https://conductscience.org/api/trials/v1/NCT00578786/registered?page=2

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