Trials / Completed
CompletedNCT03575104
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 924 (actual)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daridorexant | Daridorexant will be administered as tablets, orally, once daily in the evening. |
| OTHER | Placebo | Matching placebo will be administered as tablets, orally, once daily in the evening. |
Timeline
- Start date
- 2018-05-29
- Primary completion
- 2020-04-09
- Completion
- 2020-05-14
- First posted
- 2018-07-02
- Last updated
- 2022-03-25
- Results posted
- 2022-03-25
Locations
86 sites across 11 countries: United States, Belgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Hungary, South Korea, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03575104. Inclusion in this directory is not an endorsement.