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NCT03545191 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
A Phase 3 study of Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 930
- Enrollment target
- 20
- Study locations
NCT03545191 is a Phase 3 study of Insomnia Disorder that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 930 participants, above the 359-participant average among 8 other Insomnia Disorder trials with a reported enrollment target (159% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT03545191, a Phase 3 study of Insomnia Disorder, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 930 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Daridorexant 50 mg
- DRUG Daridorexant 25 mg
Study Locations (20)
Florida
- PAB Clinical Research - Brandon
- St. Francis Sleep Allergy and Lung Institute - Clearwater
- Innovative Clinical Research, Inc. - Hialeah
- Research Centers of America - Hollywood
- Canvas Clinical Research, LLC - Lake Worth
- BioMed Research Institute - Miami
- Clinical Site Partners, LLC - Winter Park
California
- Marvel Clinical Research - Huntington Beach
- Long Beach Clinical Trials - Long Beach
- Artemis Institute for Clinical Research - San Diego
Alabama
- Pinnacle Research Group, LLC - Anniston
- Pulmonary Associates of the Southeast/WCR - Birmingham
Arkansas
- Preferred Research Partners, Inc - Little Rock
- Woodland Research Northwest - Rogers
Indiana
- LaPorte County Institute for Clinical Research - Michigan City
Kentucky
- Kentucky Research Group - Louisville
Maryland
- Helene Emsellem, MD - Chevy Chase
Massachusetts
- Infinity Medical Research, Inc. - North Dartmouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 930 participants |
| Start Date | 2018-06-04 |
| Est. Completion | 2020-02-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03545191
The ClinicalTrials.gov registry entry for NCT03545191 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 930 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 359-participant average among 8 other Insomnia Disorder trials with a reported enrollment target (159% higher). The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Insomnia Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03545191 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03545191 about?
NCT03545191 is a clinical study titled "Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder". The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
What is the current status of trial NCT03545191?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 930 participants. The study started on 2018-06-04. Estimated completion is 2020-02-25.
What conditions does trial NCT03545191 study?
This clinical trial studies the following conditions: Insomnia Disorder.
What interventions are being tested in trial NCT03545191?
The interventions under investigation include: Placebo (OTHER), Daridorexant 50 mg (DRUG), Daridorexant 25 mg (DRUG).
Who is sponsoring clinical trial NCT03545191?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03545191 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.