Trial · NCT01884675
Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.
NCT01884675, Phase 3, Terminated, GlaxoSmithKline; results first posted 2015-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension. Trials, record NCT01884675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01884675
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.
- NCT number
- NCT01884675
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension
- Interventions
- Ambrisentan 5 mg, Placebo
- First posted
- 2013-06-24
- Last updated
- 2017-03-06
- Results first posted
- 2015-12-16
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results during Screening/Baseline period that differ by \<10%. If only one measurement was available, that measurement was used. In any cases where the protocol-defined criteria for Baseline 6MWD was not met, the Baseline value was based on the last two consecutive measurements for a participant. |
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16 | Baseline (Week 0) and Week 16 | PVR is a measure of cardiopulmonary haemodynamics. Change from Baseline was calculated as value at specified visit minus Baseline value. Baseline is the last value recorded on or prior to start of study treatment. |
| Secondary | Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | The WHO FC indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. For analyse purposes, the WHO FC Class categories of I-IV were mapped to a numeric scale of 1-4. |
| Secondary | Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | The BCR10S score was collected immediately following completion of the 6-minute walk test. Baseline data was calculated as the average of the two BCR10S values obtained following the two 6MWD tests used in determining the Baseline 6MWD. If only one measurement was available, that measurement has been used. BCR10S scores ranges from 0 to 10 (0=nothing at all, 10=extremely strong). If participant's perception or feeling was stronger than "10", i.e "extremely strong", "Maximal" - a larger number could be used, e.g. 12 or still higher i.e "Absolute maximum"). Change from Baseline was calculated as the value at specified visit minus the Baseline value. |
| Secondary | Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | From randomization to Week 16/Follow up visit (21 weeks) | Clinical worsening of CTEPH is defined by the time from randomization to the first occurrence of death, lung transplantation, hospitalization for CTEPH, atrial septostomy, addition of parenteral prostanoids, or study withdrawal due to two or more early escape criteria included: a decrease from Baseline of at least 20 percent in the distance walked during the six-minute walk test; an increase of one or more WHO functional class; worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure; new/worsening hepatomegaly, ascites, or peripheral edema; worsening echocardiographic parameters such as tricuspid annulus plane systolic excursion (TAPSE) and Tissue Doppler Imaging of the tricuspid annulus); rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (systolic blood pressure less than 85 millimeter of mercury \[mmHg\]). |
| Secondary | Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16 | Baseline (Week 0) and Week 16 | mPAP and mRAP are measures of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. |
| Secondary | Change From Baseline in Cardiac Index at Week 16 | Baseline (Week 0) and Week 16 | Cardiac index is measure of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. |
| Secondary | Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | The ratio to baseline \[BL\] in NT-proBNP was calculated as the ratio of the value at the specified time-point to the BL value and was expressed as a percent change from BL. For each treatment group, the mean change from BL at the specified time-point was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the value at the specified time-point to BL on the original scale. The GM was expressed as a percentage (100\*\[GM - 1\]). Standard Deviation(SD) is the SD of the mean change from baseline values on the log scale. |
| Secondary | Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36) | Baseline and up to Week 16/Early Withdrawal | The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock. |
| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the start of study treatment and until follow up (Week 16/Follow up) | AE is defined as 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. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. A 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 or is a congenital anomaly/birth defect or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Minutes Walking Distance (6MWD) at Week 16 | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Meters | MEDIAN |
| SECONDARY | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16 | Baseline (Week 0) and Week 16 | ITT Population. Only those participants with available data at Baseline and the specified timepoint were analysed. | Dynes*second/centimeter^5 | MEDIAN |
| SECONDARY | Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Scores on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Scores on a scale | MEDIAN |
| SECONDARY | Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | From randomization to Week 16/Follow up visit (21 weeks) | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16 | Baseline (Week 0) and Week 16 | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Millimeter of mercury (mmHg) | MEDIAN |
| SECONDARY | Change From Baseline in Cardiac Index at Week 16 | Baseline (Week 0) and Week 16 | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint were summarized. | Litre per minute per meter squared | MEDIAN |
| SECONDARY | Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36) | Baseline and up to Week 16/Early Withdrawal | ITT Population | ||
| SECONDARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the start of study treatment and until follow up (Week 16/Follow up) | ITT Population | Participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group138
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 Minutes Walking Distance (6MWD) at Week 16 | Placebo | Week 4, n=15, 17 | 5.00 | Inter-Quartile Range -1.50 to 16.50 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Ambrisentan 5mg | Week 4, n=15, 17 | 14.00 | Inter-Quartile Range 1.00 to 42.50 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Placebo | Week 8, n=14, 16 | 7.50 | Inter-Quartile Range -14.50 to 22.50 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Ambrisentan 5mg | Week 8, n=14, 16 | 26.25 | Inter-Quartile Range 3.25 to 61.25 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Placebo | Week 12, n=13, 15 | 5.50 | Inter-Quartile Range -23.00 to 39.50 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Ambrisentan 5mg | Week 12, n=13, 15 | 20.50 | Inter-Quartile Range 4.00 to 68.00 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Placebo | Week 16, n=13, 15 | -10.00 | Inter-Quartile Range -32.50 to 20.00 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Ambrisentan 5mg | Week 16, n=13, 15 | 25.00 | Inter-Quartile Range 12.00 to 49.00 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Placebo | Early Withdrawal, n=3, 2 | 7.50 | Inter-Quartile Range -46.50 to 43.50 | Meters |
| Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Ambrisentan 5mg | Early Withdrawal, n=3, 2 | 41.25 | Inter-Quartile Range 0.00 to 82.50 | Meters |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | STARTED | Ambrisentan 5mg | 17 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | COMPLETED | Ambrisentan 5mg | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Ambrisentan 5mg | 2 |
Source ClinicalTrials.gov
Adverse events78
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 | Placebo | 2 | 16 | |
| other | Oedema peripheral | General disorders | Ambrisentan 5mg | 3 | 17 | |
| other | Feeling abnormal | General disorders | Placebo | 0 | 16 | |
| other | Feeling abnormal | General disorders | Ambrisentan 5mg | 1 | 17 | |
| other | Non-cardiac chest pain | General disorders | Placebo | 0 | 16 | |
| other | Non-cardiac chest pain | General disorders | Ambrisentan 5mg | 1 | 17 | |
| other | Chest discomfort | General disorders | Placebo | 1 | 16 | |
| other | Chest discomfort | General disorders | Ambrisentan 5mg | 0 | 17 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 16 | |
| other | Headache | Nervous system disorders | Ambrisentan 5mg | 2 | 17 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Ambrisentan 5mg | ||
| Total, other adverse events | Placebo | 15 | 16 |
| Total, other adverse events | Ambrisentan 5mg | 11 | 17 |
| Total, serious adverse events | Placebo | 1 | 16 |
| Total, serious adverse events | Ambrisentan 5mg | 0 | 17 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ambrisentan 5mg vs Placebo: Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal | Trial comparisons |
| Ambrisentan 5mg vs Placebo: Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Trial comparisons |
| Ambrisentan 5mg vs Placebo: serious adverse events | 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.
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/NCT01884675
GET https://conductscience.org/api/trials/v1/NCT01884675/results?page=2