Trial · NCT02081690
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
NCT02081690, Phase 3, Terminated, Actelion; results first posted 2018-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain. Trials, record NCT02081690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02081690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
- NCT number
- NCT02081690
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan
- First posted
- 2014-03-07
- Last updated
- 2018-03-21
- Results first posted
- 2018-02-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms".The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16). |
| Primary | Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16). |
| Primary | Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | The Physical Impacts domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "not at all"/"with no difficulty at all" and value 4 corresponds to "very much"/"extremely"/ "not able at all". The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Physical Impacts domain score is determined based on the 7 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16). |
| Primary | Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | The Cognitive/Emotional Impacts domain consists of 4 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "not at all"/"with no difficulty at all" and value 4 corresponds to "very much"/"extremely"/ "not able at all". The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Cognitive/Emotional Impacts domain score is determined based on the 4 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)." |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | Validation set | Score on a scale | MEAN |
| PRIMARY | Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | Validation set | Score on a scale | MEDIAN |
| PRIMARY | Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | Validation set | Score on a scale | MEAN |
| PRIMARY | Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT | From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) | Validation set | Score on a scale | 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 |
|---|---|---|---|---|---|
| Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT | Macitentan | Cardiopulmonary Symptoms domain score at baseline | 0.90 | Standard Deviation 0.58 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT | Macitentan | Cardiopulmonary Symptoms domain score at week 8 | 0.89 | Standard Deviation 0.63 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT | Macitentan | Cardiopulmonary Symptoms domain score at week 16 | 0.89 | Standard Deviation 0.68 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT | Macitentan | Cardiovascular Symptoms domain score at baseline | 0.58 | Standard Deviation 0.62 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT | Macitentan | Cardiovascular Symptoms domain score at week 8 | 0.54 | Standard Deviation 0.62 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT | Macitentan | Cardiovascular Symptoms domain score at week 16 | 0.54 | Standard Deviation 0.65 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT | Macitentan | Physical Impacts domain score at baseline | 1.13 | Standard Deviation 0.88 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT | Macitentan | Physical Impacts domain score at week 8 | 1.15 | Standard Deviation 0.97 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT | Macitentan | Physical Impacts domain score at week 16 | 1.25 | Standard Deviation 1.00 | Score on a scale |
| Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT | Macitentan | Cogn/Emotional Impacts domain score at baseline | 0.87 | Standard Deviation 0.77 | 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 | Macitentan | 88 | |
| Overall Study | COMPLETED | Macitentan | 81 | |
| Overall Study | NOT COMPLETED | Macitentan | 7 |
Source ClinicalTrials.gov
Adverse events22
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 | Headache | Nervous system disorders | Macitentan | 11 | 88 | 12 |
| other | Hypotension | Vascular disorders | Macitentan | 5 | 88 | 6 |
| other | Oedema peripheral | General disorders | Macitentan | 8 | 88 | 8 |
| serious | Arteriovenous fistula | Vascular disorders | Macitentan | 1 | 88 | 1 |
| serious | Arthritis | Musculoskeletal and connective tissue disorders | Macitentan | 1 | 88 | 1 |
| serious | B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Macitentan | 1 | 88 | 1 |
| serious | Cardiac arrest | Cardiac disorders | Macitentan | 1 | 88 | 1 |
| serious | Cardio-respiratory arrest | Cardiac disorders | Macitentan | 1 | 88 | 1 |
| serious | Chest discomfort | General disorders | Macitentan | 1 | 88 | 1 |
| serious | Chronic kidney disease | Renal and urinary disorders | Macitentan | 1 | 88 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan | 3 | 88 |
| Total, other adverse events | Macitentan | 21 | 88 |
| Total, serious adverse events | Macitentan | 13 | 88 |
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/NCT02081690
GET https://conductscience.org/api/trials/v1/NCT02081690/events?page=2