Trial · NCT00660179
Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
NCT00660179, Phase 3, Completed, Actelion; results first posted 2014-05-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension. Trials, record NCT00660179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00660179
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
- NCT number
- NCT00660179
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 742 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- macitentan (ACT-064992), macitentan (ACT-064992), placebo
- First posted
- 2008-04-17
- Last updated
- 2015-09-28
- Results first posted
- 2014-05-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | Up to end of treatment (data presented up to month 36) | Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH). Other worsening of PAH was defined by the combined occurrence of all the following 3 events: At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks. AND worsening of PAH symptoms including at least one of the following: a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics |
| Secondary | Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event) | Up to end of treatment (data presented up to month 36) | Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment. |
| Secondary | Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event) | Up to end of treatment (data presented up to month 36) | Events of death due to any cause up to the end of treatment (plus 7 days) |
| Secondary | Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event) | Up to end of study (data presented up to month 36) | Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012). |
| Secondary | Change From Baseline to Month 6 in 6-minute Walk Distance | Baseline to month 6 | The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed. |
| Secondary | Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6 | Baseline to month 6 | Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA. |
| Secondary | Pulmonary Vascular Resistance at Baseline and Month 6 | Baseline to month 6 | In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period. |
| Secondary | Cardiac Index at Baseline and Month 6 | Baseline to month 6 | In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period. |
| Other | Summary of the First Causes of Morbidity or Mortality | Up to end of treatment (Up to 36 months) | Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH). Other worsening of PAH was defined by the combined occurrence of all the following 3 events: At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks. AND worsening of PAH symptoms including at least one of the following: a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | Up to end of treatment (data presented up to month 36) | All randomized patients | percentage of participants-Kaplan Meier | NUMBER |
| SECONDARY | Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event) | Up to end of treatment (data presented up to month 36) | All randomized patients | percentage of participants-Kaplan Meier | NUMBER |
| SECONDARY | Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event) | Up to end of treatment (data presented up to month 36) | All randomized patients | percentage of participants-Kaplan Meier | NUMBER |
| SECONDARY | Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event) | Up to end of study (data presented up to month 36) | All randomized patients | percentage of participants-Kaplan Meier | NUMBER |
| SECONDARY | Change From Baseline to Month 6 in 6-minute Walk Distance | Baseline to month 6 | All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis | metres | MEAN |
| SECONDARY | Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6 | Baseline to month 6 | All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis | participants | NUMBER |
| SECONDARY | Pulmonary Vascular Resistance at Baseline and Month 6 | Baseline to month 6 | All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study | (dyn*sec/cm^5) | MEAN |
| SECONDARY | Cardiac Index at Baseline and Month 6 | Baseline to month 6 | All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study | L/min/m^2 | MEAN |
| OTHER_PRE_SPECIFIED | Summary of the First Causes of Morbidity or Mortality | Up to end of treatment (Up to 36 months) | All randomized patients | participants | NUMBER |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | Placebo | Kaplan-Meier estimate at Month 6 | 80.1 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | ACT-064992 3 mg | Kaplan-Meier estimate at Month 6 | 89.3 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | ACT-064992 10 mg | Kaplan-Meier estimate at Month 6 | 92.7 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | Placebo | Kaplan-Meier estimate at Month 12 | 71.4 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | ACT-064992 3 mg | Kaplan-Meier estimate at Month 12 | 81.6 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | ACT-064992 10 mg | Kaplan-Meier estimate at Month 12 | 85.5 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | Placebo | Kaplan-Meier estimate at Month 18 | 61.5 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | ACT-064992 3 mg | Kaplan-Meier estimate at Month 18 | 72.5 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | ACT-064992 10 mg | Kaplan-Meier estimate at Month 18 | 79.9 | percentage of participants-Kaplan Meier | |
| Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) | Placebo | Kaplan-Meier estimate at Month 24 | 57.3 | percentage of participants-Kaplan Meier |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 250 | |
| Overall Study | STARTED | ACT-064992 3 mg | 250 | |
| Overall Study | STARTED | ACT-064992 10 mg | 242 | |
| Overall Study | COMPLETED | Placebo | 194 | |
| Overall Study | COMPLETED | ACT-064992 3 mg | 192 | |
| Overall Study | COMPLETED | ACT-064992 10 mg | 201 | |
| Overall Study | NOT COMPLETED | Placebo | 56 | |
| Overall Study | NOT COMPLETED | ACT-064992 3 mg | 58 | |
| Overall Study | NOT COMPLETED | ACT-064992 10 mg | 41 |
Source ClinicalTrials.gov
Adverse events843
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 | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 32 | 249 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | ACT-064992 3 mg | 48 | 250 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | ACT-064992 10 mg | 37 | 242 | |
| other | OEDEMA PERIPHERAL | General disorders | Placebo | 45 | 249 | |
| other | OEDEMA PERIPHERAL | General disorders | ACT-064992 3 mg | 40 | 250 | |
| other | OEDEMA PERIPHERAL | General disorders | ACT-064992 10 mg | 44 | 242 | |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo | 26 | 249 | |
| other | NASOPHARYNGITIS | Infections and infestations | ACT-064992 3 mg | 37 | 250 | |
| other | NASOPHARYNGITIS | Infections and infestations | ACT-064992 10 mg | 34 | 242 | |
| other | HEADACHE | Nervous system disorders | Placebo | 22 | 249 |
1 to 10 of 843Source ClinicalTrials.gov
See all 843 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | ACT-064992 3 mg | ||
| Total, all-cause mortality | ACT-064992 10 mg | ||
| Total, other adverse events | Placebo | 219 | 249 |
| Total, other adverse events | ACT-064992 3 mg | 227 | 250 |
| Total, other adverse events | ACT-064992 10 mg | 222 | 242 |
| Total, serious adverse events | Placebo | 137 | 249 |
| Total, serious adverse events | ACT-064992 3 mg | 130 | 250 |
| Total, serious adverse events | ACT-064992 10 mg | 109 | 242 |
Source ClinicalTrials.gov
Papers10
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.
For software
Read this trial from software.
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