Trial · NCT00380068
Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
NCT00380068, Phase 3, Completed, Gilead Sciences; results first posted 2010-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension. Trials, record NCT00380068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00380068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
- NCT number
- NCT00380068
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Pulmonary Hypertension
- Interventions
- Ambrisentan
- First posted
- 2006-09-25
- Last updated
- 2012-04-05
- Results first posted
- 2010-11-19
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD) | Baseline to Week 24 | |
| Secondary | Change From Baseline to Week 24 in Borg Dyspnea Index | Baseline to Week 24 | Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum. |
| Secondary | Change From Baseline to Week 48 in Borg Dyspnea Index | Baseline to Week 48 | Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum. |
| Secondary | Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP) | Baseline to Week 24 | |
| Secondary | Percent Change From Baseline to Week 48 in BNP | Baseline to Week 48 | |
| Secondary | Change From Baseline to Week 24 in WHO Functional Class | Baseline to Week 24 | Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of \<= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0. |
| Secondary | Change From Baseline to Week 48 in WHO Functional Class | Baseline to Week 48 | Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of \<= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0. |
| Secondary | Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale | Baseline to Week 24 | Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10. |
| Secondary | Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale | Baseline to Week 48 | Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10. |
| Secondary | Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24 | Baseline to Week 24 | Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD) | Baseline to Week 24 | Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline 6MWD data. | meters | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Borg Dyspnea Index | Baseline to Week 24 | Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline Borg Dyspnea Index data. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 48 in Borg Dyspnea Index | Baseline to Week 48 | Full Analysis Set. Observed data. 114 participants were excluded from the analysis due to lack of Week 48 Borg Dyspnea Index data. | Units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP) | Baseline to Week 24 | Full Analysis Set. Last Observation Carried forward. 10 participants were excluded from the analysis due to lack of baseline or post-baseline BNP data. | Percent change in BNP | GEOMETRIC_MEAN |
| SECONDARY | Percent Change From Baseline to Week 48 in BNP | Baseline to Week 48 | Full Analysis Set. Observed data. 111 participants were excluded from the analysis due to lack of baseline or Week 48 BNP data. | Percent change in BNP | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to Week 24 in WHO Functional Class | Baseline to Week 24 | Full Analysis Set. Last Observation Carried Forward. 3 participants were not analyzed due to lack of post-baseline WHO functional class data. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 48 in WHO Functional Class | Baseline to Week 48 | Full Analysis Set. Observed Data. 3 participants were not analyzed due to lack of post-baseline WHO functional class data. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale | Baseline to Week 24 | Full Analysis Set. Last Observation Carried forward. 26 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale | Baseline to Week 48 | Full Analysis Set. Last Observation Carried forward. 25 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data. | Units on a scale | MEAN |
| SECONDARY | Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24 | Baseline to Week 24 | Full analysis set. Participants who were lost to follow-up were censored at the date of last contact. | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD) | Ambrisentan | 20.5 | Standard Deviation 65.64 | meters | |
| Change From Baseline to Week 24 in Borg Dyspnea Index | Ambrisentan | -0.5 | Standard Deviation 2.18 | Units on a scale | |
| Change From Baseline to Week 48 in Borg Dyspnea Index | Ambrisentan | -0.6 | Standard Deviation 1.91 | Units on a scale | |
| Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP) | Ambrisentan | -25.5 | 95% Confidence Interval -33.6 to -16.3 | Percent change in BNP | |
| Percent Change From Baseline to Week 48 in BNP | Ambrisentan | -29.2 | 95% Confidence Interval -39.8 to -16.6 | Percent change in BNP | |
| Change From Baseline to Week 24 in WHO Functional Class | Ambrisentan | -3 | 0 | Percentage of participants | |
| Change From Baseline to Week 24 in WHO Functional Class | Ambrisentan | -2 | 0.9 | Percentage of participants | |
| Change From Baseline to Week 24 in WHO Functional Class | Ambrisentan | -1 | 22.2 | Percentage of participants | |
| Change From Baseline to Week 24 in WHO Functional Class | Ambrisentan | 0 | 70.1 | Percentage of participants | |
| Change From Baseline to Week 24 in WHO Functional Class | Ambrisentan | 1 | 6.8 | Percentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ambrisentan | 224 | |
| Overall Study | COMPLETED | Ambrisentan | 155 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 69 |
Source ClinicalTrials.gov
Adverse events175
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 | arthralgia | Musculoskeletal and connective tissue disorders | Ambrisentan | 20 | 224 | |
| other | back pain | Musculoskeletal and connective tissue disorders | Ambrisentan | 24 | 224 | |
| other | brain natriuretic peptide increased | Investigations | Ambrisentan | 18 | 224 | |
| other | cough | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 29 | 224 | |
| other | depression | Psychiatric disorders | Ambrisentan | 27 | 224 | |
| other | diarrhoea | Gastrointestinal disorders | Ambrisentan | 22 | 224 | |
| other | dizziness | Nervous system disorders | Ambrisentan | 30 | 224 | |
| other | dyspnoea | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 48 | 224 | |
| other | fatigue | General disorders | Ambrisentan | 39 | 224 | |
| other | flushing | Vascular disorders | Ambrisentan | 16 | 224 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | ||
| Total, other adverse events | Ambrisentan | 203 | 224 |
| Total, serious adverse events | Ambrisentan | 97 | 224 |
Source ClinicalTrials.gov
Papers0
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.
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