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NCT02554903 · ClinicalTrials.gov registry record · Phase 2
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
A Phase 2 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT02554903 is a Phase 2 study that has completed, run by Actelion. The registered enrollment target is 57 participants.
The verdict
NCT02554903, a Phase 2 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation. To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation. Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function in subjects with PH after LVAD implantation. To explore the potential effect of macitentan 10 mg as compared to placebo on selected clinical events in subjects with PH after LVAD implantation. To explore the potential effect of macitentan 10 mg as compared to placebo on renal function as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.
Interventions
- DRUG Placebo sugar pill
- DRUG Macitentan 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2016-03-28 |
| Est. Completion | 2020-03-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02554903
The ClinicalTrials.gov registry entry for NCT02554903 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo sugar pill is the first listed.
NCT02554903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02554903 about?
NCT02554903 is a clinical study titled "Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation". STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Secondary objectives To evaluate the effect of macitenta...
What is the current status of trial NCT02554903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2016-03-28. Estimated completion is 2020-03-13.
What interventions are being tested in trial NCT02554903?
The interventions under investigation include: Placebo sugar pill (DRUG), Macitentan 10mg (DRUG).
Who is sponsoring clinical trial NCT02554903?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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