Trial · NCT00424021
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
NCT00424021, Phase 2, Completed, Gilead Sciences; results first posted 2012-01-27
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ConductScience Library. Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension. Trials, record NCT00424021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424021
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
- NCT number
- NCT00424021
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Pulmonary Hypertension
- Interventions
- ambrisentan
- First posted
- 2007-01-18
- Last updated
- 2012-01-27
- Results first posted
- 2012-01-27
- Limitations and caveats
The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 334 | The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study. |
| Primary | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 329.3 | The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study. |
| Primary | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 329.3 | The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study. |
| Secondary | Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | The 6MWT 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.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Secondary | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48) | 24 weeks (Week 24 to Week 48) | The 6MWT 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.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Secondary | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108) | 84 weeks (Week 24 to Week 108) | The 6MWT 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.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Secondary | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156) | 132 weeks (Week 24 to Week 156) | The 6MWT 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.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Secondary | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204) | 180 weeks (Week 24 to Week 204) | The 6MWT 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.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Secondary | Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, 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 (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48) | 24 weeks (Week 24 to Week 48) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 334 | The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study. | Participants | NUMBER |
| SECONDARY | Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Meters | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48) | 24 weeks (Week 24 to Week 48) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Meters | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108) | 84 weeks (Week 24 to Week 108) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Meters | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156) | 132 weeks (Week 24 to Week 156) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Meters | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204) | 180 weeks (Week 24 to Week 204) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Meters | MEAN |
| SECONDARY | Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48) | 24 weeks (Week 24 to Week 48) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108) | 84 weeks (Week 24 to Week 108) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156) | 132 weeks (Week 24 to Week 156) | Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation. | Units on a Scale | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group843
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 1 mg | Abdominal Pain NOS | 0 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 2.5 mg | Abdominal Pain NOS | 1 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 5 mg | Abdominal Pain NOS | 1 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 10 mg | Abdominal Pain NOS | 0 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 1 mg | Alanine Aminotransferase Increased | 0 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 2.5 mg | Alanine Aminotransferase Increased | 0 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 5 mg | Alanine Aminotransferase Increased | 0 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 10 mg | Alanine Aminotransferase Increased | 2 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 1 mg | Anaemia NOS | 0 | Participants | |
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | 2.5 mg | Anaemia NOS | 1 | Participants |
1 to 10 of 843Source ClinicalTrials.gov
See all 843 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| NCT00046319 Study Period | STARTED | 1 mg | 16 | |
| NCT00046319 Study Period | STARTED | 2.5 mg | 19 | |
| NCT00046319 Study Period | STARTED | 5 mg | 16 | |
| NCT00046319 Study Period | STARTED | 10 mg | 13 | |
| NCT00046319 Study Period | COMPLETED | 1 mg | 15 | |
| NCT00046319 Study Period | COMPLETED | 2.5 mg | 16 | |
| NCT00046319 Study Period | COMPLETED | 5 mg | 15 | |
| NCT00046319 Study Period | COMPLETED | 10 mg | 12 | |
| NCT00046319 Study Period | NOT COMPLETED | 1 mg | 1 | |
| NCT00046319 Study Period | NOT COMPLETED | 2.5 mg | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,428
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 | Anaemia NOS | Blood and lymphatic system disorders | 1 mg | 0 | 2 | 0 |
| other | Anaemia NOS | Blood and lymphatic system disorders | 2.5 mg | 2 | 7 | 5 |
| other | Anaemia NOS | Blood and lymphatic system disorders | 5 mg | 2 | 19 | 5 |
| other | Anaemia NOS | Blood and lymphatic system disorders | 10 mg | 4 | 26 | 5 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 1 mg | 0 | 2 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 2.5 mg | 1 | 7 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 5 mg | 1 | 19 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 10 mg | 0 | 26 | 0 |
| other | Leukopenia NOS | Blood and lymphatic system disorders | 1 mg | 0 | 2 | 0 |
| other | Leukopenia NOS | Blood and lymphatic system disorders | 2.5 mg | 1 | 7 | 1 |
1 to 10 of 1,428Source ClinicalTrials.gov
See all 1,428 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 mg | ||
| Total, all-cause mortality | 2.5 mg | ||
| Total, all-cause mortality | 5 mg | ||
| Total, all-cause mortality | 10 mg | ||
| Total, other adverse events | 1 mg | 2 | 2 |
| Total, other adverse events | 2.5 mg | 7 | 7 |
| Total, other adverse events | 5 mg | 19 | 19 |
| Total, other adverse events | 10 mg | 26 | 26 |
| Total, serious adverse events | 1 mg | 0 | 2 |
| Total, serious adverse events | 2.5 mg | 2 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT00424021
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