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NCT01841762 · ClinicalTrials.gov registry record · Phase 3
Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 284
- Enrollment target
NCT01841762 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 284 participants.
The verdict
NCT01841762, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 284 participants
- Enrollment target
Study Summary
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily. The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.
Interventions
- DRUG Macitentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2013-04-01 |
| Est. Completion | 2015-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01841762
The ClinicalTrials.gov registry entry for NCT01841762 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 284 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 1 intervention - of which Macitentan is the first listed.
NCT01841762 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01841762 about?
NCT01841762 is a clinical study titled "Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument". SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive maciten...
What is the current status of trial NCT01841762?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2013-04-01. Estimated completion is 2015-11-01.
What interventions are being tested in trial NCT01841762?
The interventions under investigation include: Macitentan (DRUG).
Who is sponsoring clinical trial NCT01841762?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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