Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03679884 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 804
- Enrollment target
NCT03679884: Completed Phase 3 study, sponsored by Idorsia Pharmaceuticals.
NCT03679884 is a Phase 3 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 804 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03679884, a Phase 3 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 804 participants
- Enrollment target
Study Summary
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Primary Outcome
The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section "Adverse events".
Interventions
- DRUG Placebo
- DRUG Daridorexant 50 mg
- DRUG Daridorexant 25 mg
- DRUG Daridorexant 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 804 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2021-02-22 |
| Phase | Phase 3 |
What the finished NCT03679884 record still lists
NCT03679884 is an interventional study that assigns participants to a tested intervention. The registered 804 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03679884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03679884 about?
NCT03679884 is a clinical study titled "Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep". Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
What is the current status of trial NCT03679884?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 804 participants. The study started on 2018-10-09. Estimated completion is 2021-02-22.
What interventions are being tested in trial NCT03679884?
The interventions under investigation include: Placebo (DRUG), Daridorexant 50 mg (DRUG), Daridorexant 25 mg (DRUG), Daridorexant 10 mg (DRUG).
Who is sponsoring clinical trial NCT03679884?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03679884's enrollment target sits among peer trials
804 412th of 2000 higher than 1,588 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04423211 · 804 participants · Phase 3
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
- NCT06522022 · 804 participants · NA
PTSD Screening in Pregnant Black Women
- NCT04613596 · 806 participants · Phase 2
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
- NCT06065098 · 806 participants · NA
Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI