Trial · NCT01338636
An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH)
NCT01338636, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2017-05-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH). Trials, record NCT01338636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01338636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT01338636
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 30 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Exercise-induced Pulmonary Arterial Hypertension
- Interventions
- Ambrisentan
- First posted
- 2011-04-19
- Last updated
- 2022-01-18
- Results first posted
- 2017-05-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP) | Baseline to Week 24 | mPAP is measure of the blood pressure found in the main artery of the lung. TPG is the difference between mean pulmonary arterial pressure and left atrial pressure. PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch. |
| Primary | Change From Baseline in Peak Exercise Pulmonary Vascular Resistance (PVR) | Baseline to Week 24 | PVR is the resistance offered by the pulmonary circulatory system. |
| Primary | Change From Baseline in Peak Exercise Pulmonary Vascular Compliance (PVC ) | Baseline to Week 24 | PVC is a measure of a pulmonary vein's ability to expand. |
| Primary | Change From Baseline in Peak Exercise Cardiac Output (CO) | Baseline to Week 24 | CO is the amount of blood pumped by the heart per minute. |
| Primary | Change From Baseline in Peak Exercise Maximum Oxygen Uptake (VO2max) | Baseline to Week 24 | VO2max is the measurement of the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. |
| Secondary | Change From Baseline in 6-minute Walk Distance (6MWD) | Baseline to Week 24 | 6MWD is the distance walked by the participant in 6 minutes. |
| Secondary | Borg Dyspnea Scale Score | Baseline and Week 24 | The Borg Dyspnea Scale measures how breathless the participant feels. Scores range from 0 (no shortness of breath) to 10 (more short of breath than ever experienced). (minimum score 0, maximum score 10 with 10 being worsening outcome) |
| Secondary | World Health Organization Functional Class (WHO FC) | Baseline and Week 24 | The WHO FC categorizes cardiac disability using four classes, ranging from Class 1 (without limitation of physical activity) to Class 4 (inability to carry on any physical activity without discomfort). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP) | Baseline to Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Peak Exercise Pulmonary Vascular Resistance (PVR) | Baseline to Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | Woods units (WU) | MEAN |
| PRIMARY | Change From Baseline in Peak Exercise Pulmonary Vascular Compliance (PVC ) | Baseline to Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | mL/mmHg | MEAN |
| PRIMARY | Change From Baseline in Peak Exercise Cardiac Output (CO) | Baseline to Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | L/min | MEAN |
| PRIMARY | Change From Baseline in Peak Exercise Maximum Oxygen Uptake (VO2max) | Baseline to Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | percent predicted | MEAN |
| SECONDARY | Change From Baseline in 6-minute Walk Distance (6MWD) | Baseline to Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | meters | MEAN |
| SECONDARY | Borg Dyspnea Scale Score | Baseline and Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | score on a scale | MEAN |
| SECONDARY | World Health Organization Functional Class (WHO FC) | Baseline and Week 24 | The analysis population included evaluable participants who completed the 24-week treatment period. | class | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP) | Exercise-induced PAH | mPAP | -5.2 | Standard Deviation 5.6 | mmHg |
| Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP) | Exercise-induced PAH | TPG | -7.1 | Standard Deviation 8.0 | mmHg |
| Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP) | Exercise-induced PAH | PCWP | 2.9 | Standard Deviation 5.6 | mmHg |
| Change From Baseline in Peak Exercise Pulmonary Vascular Resistance (PVR) | Exercise-induced PAH | -0.9 | Standard Deviation 0.7 | Woods units (WU) | |
| Change From Baseline in Peak Exercise Pulmonary Vascular Compliance (PVC ) | Exercise-induced PAH | 0.8 | Standard Deviation 1.4 | mL/mmHg | |
| Change From Baseline in Peak Exercise Cardiac Output (CO) | Exercise-induced PAH | 2.3 | Standard Deviation 1.4 | L/min | |
| Change From Baseline in Peak Exercise Maximum Oxygen Uptake (VO2max) | Exercise-induced PAH | 4.4 | Standard Deviation 2.6 | percent predicted | |
| Change From Baseline in 6-minute Walk Distance (6MWD) | Exercise-induced PAH | 34.8 | Standard Deviation 73.2 | meters | |
| Borg Dyspnea Scale Score | Exercise-induced PAH | Baseline | 5.1 | Standard Deviation 2.8 | score on a scale |
| Borg Dyspnea Scale Score | Exercise-induced PAH | Week 24 | 3.0 | Standard Deviation 0.9 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exercise-induced PAH | 30 | |
| Overall Study | COMPLETED | Exercise-induced PAH | 22 | |
| Overall Study | NOT COMPLETED | Exercise-induced PAH | 8 |
Source ClinicalTrials.gov
Adverse events14
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 | Peripheral edema | Metabolism and nutrition disorders | Exercise-induced PAH | 7 | 30 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Exercise-induced PAH | 7 | 30 | |
| other | Headache | Nervous system disorders | Exercise-induced PAH | 5 | 30 | |
| other | Flushing | Vascular disorders | Exercise-induced PAH | 4 | 30 | |
| other | Increased cough | Respiratory, thoracic and mediastinal disorders | Exercise-induced PAH | 4 | 30 | |
| other | Joint and body pain | Musculoskeletal and connective tissue disorders | Exercise-induced PAH | 3 | 30 | |
| other | Rash | Skin and subcutaneous tissue disorders | Exercise-induced PAH | 2 | 30 | |
| other | Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Exercise-induced PAH | 2 | 30 | |
| other | Gastrointestinal infection | Gastrointestinal disorders | Exercise-induced PAH | 2 | 30 | |
| other | Jaw pain | Musculoskeletal and connective tissue disorders | Exercise-induced PAH | 1 | 30 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exercise-induced PAH | ||
| Total, other adverse events | Exercise-induced PAH | 25 | 30 |
| Total, serious adverse events | Exercise-induced PAH | 0 | 30 |
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.
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/NCT01338636
GET https://conductscience.org/api/trials/v1/NCT01338636/registered