Trial · NCT01808313
Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)
NCT01808313, Phase 3, Completed, GlaxoSmithKline; results first posted 2015-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH). Trials, record NCT01808313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01808313
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT01808313
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 134 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Vascular Disease
- Interventions
- ambrisentan
- First posted
- 2013-03-11
- Last updated
- 2017-06-06
- Results first posted
- 2015-05-12
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12 | Baseline and Week 12 | The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10 percent (%). If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values. |
| Secondary | Change From Baseline in 6MWT at Week 24 | Baseline and Week 24 | The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10%. If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values. |
| Secondary | Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | The WHO FC was determined by the investigator as follows: Class I- Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity, II- Participants with PH resulting in slight limitation of physical activity, III- Participants with PH resulting in marked limitation of physical activity, IV- Participants with PH with inability to carry out any physical activity without symptoms. Changes from Baseline in functional class were summarized at Weeks 12 and 24. The number of participants improving by 2 classes, improving by 1 class, not changing, worsening by 1 class or worsening by 2 classes from Baseline at Weeks 12 and 24 were evaluated. The Baseline value was the last non-missing assessment value before treatment. Only participants with non-missing Baseline values and at least one non-missing post-Baseline value of the response variable were included. The last observation carried forward method was used to impute missing values. |
| Secondary | Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from Baseline was calculated as the Week 12 and 24 values minus the Baseline values. The BDI indicates the degree of exertion, breathlessness, fatigue, or difficulty breathing after completion of the 6MWT. The lower values, 0 as the lowest, indicates no exertion, fatigue, or breathlessness felt, and 10 would be the maximum amount of exertion felt as assessed by each participant. The last observation carried forward method was used to impute missing values. |
| Secondary | Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate maker of heart failure and was measured by a central laboratory. Mean change from Baseline at Weeks 12 and 24 were calculated as the Weeks 12 and 24 values minus the Baseline values.Observed data was analyzed (no imputation technique was performed for missing data). Log transformed mean change from Baseline at Weeks 12 and 24 data are summarized. |
| Secondary | Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event | Baseline up to Week 24 | Time to clinical worsening is defined as the time from Baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or Investigational product (IP) discontinuation (discon) due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events during 12 and 24 Weeks. |
| Secondary | Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation | From the start of study treatment up to Week 24 | An adverse event (AE) is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, or important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. |
| Secondary | Number of Participants With Physical Examination Findings | Baseline, Week 12 and Week 24 | Complete physical examinations of each participant by the investigator were performed at the Screening Visit, Week 12 and Week 24 Visit/Early withdrawal visits. The physical examination included an examination of the following: general appearance, skin, head, ears, eyes, nose, throat, neck, thyroid, lymph nodes, cardiovascular system, respiratory system, abdomen, musculoskeletal system, neurological system and height. Physical examination summary results were not collected therefore there is no data to present for this outcome measure. |
| Secondary | Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | Heart rate was measured in order to monitor vital signs by the 12-lead ECG at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment at Weeks 12 and 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment. |
| Secondary | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | The ECG parameters, PR interval, QRS duration, uncorrected QT interval, QTcB were measured at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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 6-minutes Walk Test (6MWT) at Week 12 | Baseline and Week 12 | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and had an efficacy assessment performed both at Baseline and after administration of the study medication | Meters | MEAN |
| SECONDARY | Change From Baseline in 6MWT at Week 24 | Baseline and Week 24 | ITT Population. | Meters | MEAN |
| SECONDARY | Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population. Only those participants available at the specified time points were analyzed (represented by number of participants \[n\]=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflect everyone in the ITT Population. | log(ng/L) | MEAN |
| SECONDARY | Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event | Baseline up to Week 24 | Safety Population: This population comprised of all participants who received at least one dose of study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation | From the start of study treatment up to Week 24 | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Physical Examination Findings | Baseline, Week 12 and Week 24 | Safety Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Beats per minute | MEAN |
| SECONDARY | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Milliseconds | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group328
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 6-minutes Walk Test (6MWT) at Week 12 | Ambrisentan | 53.59 | Standard Deviation 64.494 | Meters | |
| Change From Baseline in 6MWT at Week 24 | Ambrisentan | 64.36 | Standard Deviation 91.173 | Meters | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Improved by 2 classes at Week 12 | 0 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Improved by 1 class at Week 12 | 44 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Not changing at Week 12 | 84 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Worsened by 1 class at Week 12 | 4 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Worsened by 2 classes at Week 12 | 1 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Improved by 2 classes at Week 24 | 0 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Improved by 1 class at Week 24 | 51 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Ambrisentan | Not changing at Week 24 | 77 | Participants |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 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 | 133 | |
| Overall Study | COMPLETED | Ambrisentan | 123 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 10 |
Source ClinicalTrials.gov
Adverse events26
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 | 15 | 134 | |
| other | Flushing | Vascular disorders | Ambrisentan | 11 | 134 | |
| other | Alanine aminotransferase increased | Investigations | Ambrisentan | 9 | 134 | |
| other | Aspartate aminotransferase increased | Investigations | Ambrisentan | 9 | 134 | |
| other | Blood bilirubin increased | Investigations | Ambrisentan | 9 | 134 | |
| other | Gamma-glutamyltransferase increased | Investigations | Ambrisentan | 7 | 134 | |
| other | Headache | Nervous system disorders | Ambrisentan | 7 | 134 | |
| other | Nausea | Gastrointestinal disorders | Ambrisentan | 7 | 134 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 6 | 134 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Ambrisentan | 6 | 134 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 | 59 | 134 |
| Total, serious adverse events | Ambrisentan | 11 | 134 |
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 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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The record and each of its lists are JSON, twenty rows a page. No key.
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