Trial · NCT02070991
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
NCT02070991, Phase 2, Completed, Actelion; results first posted 2019-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction. Trials, record NCT02070991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02070991
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
- NCT number
- NCT02070991
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Hypertension
- Interventions
- Macitentan, Placebo
- First posted
- 2014-02-25
- Last updated
- 2019-05-15
- Results first posted
- 2019-05-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day | The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline. |
| Secondary | NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest | From randomization up to end of treatment period (Week 12) | |
| Secondary | PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest | From randomization up to end of treatment period (Week 12) | Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC). |
| Secondary | Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) | From randomization up to end of treatment period (Week 12) | |
| Secondary | Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) | From randomization up to end of treatment period (Week 12) | |
| Secondary | Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP) | From randomization up to end of treatment period (Week 12) | |
| Secondary | Change From Baseline to Week 12 in Cardiac Index (CI) | From randomization up to end of treatment period (Week 12) | |
| Secondary | Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG) | From randomization up to end of treatment period (Week 12) |
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 | Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest | From randomization up to end of treatment period (Week 12) | The values of 6 patients are missing in both the macitentan and the placebo group. | percentage of baseline NT-proBNP | GEOMETRIC_MEAN |
| SECONDARY | PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest | From randomization up to end of treatment period (Week 12) | The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing. | percentage of baseline PVR | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) | From randomization up to end of treatment period (Week 12) | The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing. | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) | From randomization up to end of treatment period (Week 12) | The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing. | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP) | From randomization up to end of treatment period (Week 12) | The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing. | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Cardiac Index (CI) | From randomization up to end of treatment period (Week 12) | The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing. | L/min/m^2 | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG) | From randomization up to end of treatment period (Week 12) | The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Macitentan | Total participants with at least one condition | 7 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Placebo | Total participants with at least one condition | 4 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Macitentan | Participants with fluid retention | 7 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Placebo | Participants with fluid retention | 3 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Macitentan | Participants with worsening in NYHA FC | 1 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Placebo | Participants with worsening in NYHA FC | 2 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Macitentan | Participants with both conditions | 1 | Participants | |
| Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment | Placebo | Participants with both conditions | 1 | Participants | |
| NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest | Macitentan | 91.56 | 95% Confidence Interval 72.37 to 115.83 | percentage of baseline NT-proBNP | |
| NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest | Placebo | 118.90 | 95% Confidence Interval 92.53 to 152.78 | percentage of baseline NT-proBNP |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan | 31 | |
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | COMPLETED | Macitentan | 28 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Macitentan | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events80
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 | Anaemia | Blood and lymphatic system disorders | Macitentan | 2 | 31 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 32 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Macitentan | 1 | 31 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 2 | 32 | 2 |
| other | Mitral valve incompetence | Cardiac disorders | Macitentan | 2 | 31 | 2 |
| other | Mitral valve incompetence | Cardiac disorders | Placebo | 0 | 32 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Macitentan | 3 | 31 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 32 | 1 |
| other | Nausea | Gastrointestinal disorders | Macitentan | 1 | 31 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 32 | 2 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan | 2 | 31 |
| Total, all-cause mortality | Placebo | 0 | 32 |
| Total, other adverse events | Macitentan | 16 | 31 |
| Total, other adverse events | Placebo | 15 | 32 |
| Total, serious adverse events | Macitentan | 11 | 31 |
| Total, serious adverse events | Placebo | 6 | 32 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Macitentan vs Placebo: deaths from any cause | Trial comparisons |
| Macitentan 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/NCT02070991
GET https://conductscience.org/api/trials/v1/NCT02070991/results?page=2