Trial · NCT01847014
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
NCT01847014, Phase 3, Terminated, Actelion; results first posted 2018-08-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument. Trials, record NCT01847014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01847014
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
- NCT number
- NCT01847014
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan
- First posted
- 2013-05-06
- Last updated
- 2018-08-22
- Results first posted
- 2018-08-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incident Rate of Adverse Events (AEs). | From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug). | Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incident Rate of Adverse Events (AEs). | From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug). | Four participants represent the Extension Analysis Set, who transitioned from completion of SYMPHONY AC-055-401 to this open-label extension clinical trial. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incident Rate of Adverse Events (AEs). | Macitentan | Participants with severe intensity AEs | 1 | Participants | |
| Incident Rate of Adverse Events (AEs). | Macitentan | Participants with AEs | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Extension Visit | STARTED | Macitentan | 4 | |
| Baseline Extension Visit | COMPLETED | Macitentan | 4 | |
| Baseline Extension Visit | NOT COMPLETED | Macitentan | 0 | |
| Completion of Extension Study | STARTED | Macitentan | 4 | |
| Completion of Extension Study | COMPLETED | Macitentan | 0 | |
| Completion of Extension Study | NOT COMPLETED | Macitentan | 4 |
Source ClinicalTrials.gov
Adverse events23
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 | Hyperlipidaemia | Metabolism and nutrition disorders | Macitentan | 1 | 4 | 1 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Macitentan | 1 | 4 | 1 |
| other | Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | Macitentan | 1 | 4 | 1 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Macitentan | 1 | 4 | 1 |
| other | Right Heart Failure | Cardiac disorders | Macitentan | 1 | 4 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Macitentan | 1 | 4 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Macitentan | 1 | 4 | 1 |
| other | Nausea | Gastrointestinal disorders | Macitentan | 1 | 4 | 1 |
| other | Vomiting | Gastrointestinal disorders | Macitentan | 1 | 4 | 1 |
| other | Chest Pain | General disorders | Macitentan | 1 | 4 | 1 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan | 0 | 4 |
| Total, other adverse events | Macitentan | 3 | 4 |
| Total, serious adverse events | Macitentan | 1 | 4 |
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/NCT01847014
GET https://conductscience.org/api/trials/v1/NCT01847014/events?page=2