Trial · NCT02651272
Macitentan in Pulmonary Hypertension of Sickle Cell Disease
NCT02651272, Phase 2, Terminated, Boston University; results first posted 2020-12-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Macitentan in Pulmonary Hypertension of Sickle Cell Disease. Trials, record NCT02651272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02651272
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Macitentan in Pulmonary Hypertension of Sickle Cell Disease
- NCT number
- NCT02651272
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Pulmonary Hypertension, Sickle Cell Disease
- Interventions
- macitentan
- First posted
- 2016-01-08
- Last updated
- 2020-12-08
- Results first posted
- 2020-12-08
- Limitations and caveats
- Early termination as unable to enroll participants.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | 20 weeks | The occurrence of treatment emergent AEs includes having any of the following: vaso-occlusive crises requiring hospitalization; acute congestive heart failure; hypotension (defined as a mean arterial pressure less than 60mmHg); decrease in hemoglobin concentration by greater than 1 g/dL. |
| Secondary | Change in Right Arterial Pressure (RAP) | Baseline, 16 weeks | RAP will be assessed by right heart catheterization. Normal range is 2-6 mmHg. |
| Secondary | Change in Systolic Right Ventricular Pressure (RVSP) | Baseline, 16 weeks | RVSP will be assessed by right heart catheterization. Normal range is 15-25 mmHg. |
| Secondary | Change in Diastolic Pulmonary Artery Pressure (PADP) | Baseline, 16 weeks | PADP will be assessed by right heart catheterization. Normal range is 8-15 mmHg. |
| Secondary | Change in Systolic Pulmonary Artery Pressure (SPAP) | Baseline, 16 weeks | SPAP will be assessed by right heart catheterization. Normal range is 15-25 mm Hg. |
| Secondary | Change in Systemic Vascular Resistance Index (SVR) | Baseline, Week 16 | Systemic vascular resistance (SVR) will be assessed with this formula Systemic Vascular Resistance (SVR) = 80x(Mean Arterial Pressure - Mean Venous Pressure or CVP) / Cardiac Output. Normal range is 800 - 1200 dynes-sec/cm-5. |
| Secondary | Change in Cardiac Index (CI) | Baseline to Week 16 | Cardiac index (CI) will be measured in L/min/m\^2. The normal range for CI is 2.5 to 4 L/min/m\^2. |
| Secondary | Change in 6 Minute Walk Distance (6MWD) | Baseline, 16 weeks | The 6 minute walk test (6MWT) assesses distance walked over 6 minutes (6MWD) as a sub-maximal test of aerobic capacity/endurance. Participants will walk at their normal pace for 6 minutes. |
| Secondary | Assess Change of Borg Dyspnea Index | Baseline, 16 weeks | The Borg Dyspnea Index (BDI) is a 0 to 10 rated self reported numerical score used to measure dyspnea during submaximal exercise and will be administered immediately following the 6MWT. The higher the score, the more dyspnea. |
| Secondary | World Health Organization (WHO) Functional Classification | 16 weeks | The WHO functional classification will be assessed and documented with the WHO Class. Class I Patients with pulmonary hypertension (PH) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PH resulting in a slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity. The Class is inversely related to function. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events | 20 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Right Arterial Pressure (RAP) | Baseline, 16 weeks | mmHg | NUMBER | |
| SECONDARY | Change in Systolic Right Ventricular Pressure (RVSP) | Baseline, 16 weeks | mmHg | NUMBER | |
| SECONDARY | Change in Diastolic Pulmonary Artery Pressure (PADP) | Baseline, 16 weeks | mmHg | NUMBER | |
| SECONDARY | Change in Systolic Pulmonary Artery Pressure (SPAP) | Baseline, 16 weeks | mmHg | NUMBER | |
| SECONDARY | Change in Systemic Vascular Resistance Index (SVR) | Baseline, Week 16 | dynes-sec/cm-5. | NUMBER | |
| SECONDARY | Change in Cardiac Index (CI) | Baseline to Week 16 | L/min/m^2 | NUMBER | |
| SECONDARY | Change in 6 Minute Walk Distance (6MWD) | Baseline, 16 weeks | meters | NUMBER | |
| SECONDARY | Assess Change of Borg Dyspnea Index | Baseline, 16 weeks | score on a scale | NUMBER | |
| SECONDARY | World Health Organization (WHO) Functional Classification | 16 weeks | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Macitentan | 0 | Participants | ||
| Change in Right Arterial Pressure (RAP) | Macitentan | -5 | mmHg | ||
| Change in Systolic Right Ventricular Pressure (RVSP) | Macitentan | 3 | mmHg | ||
| Change in Diastolic Pulmonary Artery Pressure (PADP) | Macitentan | -5 | mmHg | ||
| Change in Systolic Pulmonary Artery Pressure (SPAP) | Macitentan | 7 | mmHg | ||
| Change in Systemic Vascular Resistance Index (SVR) | Macitentan | -528 | dynes-sec/cm-5. | ||
| Change in Cardiac Index (CI) | Macitentan | .23 | L/min/m^2 | ||
| Change in 6 Minute Walk Distance (6MWD) | Macitentan | -89 | meters | ||
| Assess Change of Borg Dyspnea Index | Macitentan | 6 | score on a scale | ||
| World Health Organization (WHO) Functional Classification | Macitentan | Class 1 | 0 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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 | 4 | |
| Overall Study | COMPLETED | Macitentan | 1 | |
| Overall Study | NOT COMPLETED | Macitentan | 3 |
Source ClinicalTrials.gov
Adverse events1
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 | nausea and vomiting | Gastrointestinal disorders | Macitentan | 1 | 1 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan | 0 | 1 |
| Total, other adverse events | Macitentan | 1 | 1 |
| Total, serious adverse events | Macitentan | 0 | 1 |
Source ClinicalTrials.gov
Papers6
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02651272
GET https://conductscience.org/api/trials/v1/NCT02651272/registered