Trial · NCT03679884
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT03679884, Phase 3, Completed, Idorsia Pharmaceuticals Ltd.; results first posted 2022-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep. Trials, record NCT03679884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03679884
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
- NCT number
- NCT03679884
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 804 participants, actual
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Conditions
- Insomnia Disorder
- Interventions
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo
- First posted
- 2018-09-21
- Last updated
- 2022-03-02
- Results first posted
- 2022-03-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total no. of Subjects With at Least One TEAE | TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks. | 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". |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total no. of Subjects With at Least One TEAE | TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total no. of Subjects With at Least One TEAE | Daridorexant 10 mg | 53 | Participants | ||
| Total no. of Subjects With at Least One TEAE | Daridorexant 25 mg | 103 | Participants | ||
| Total no. of Subjects With at Least One TEAE | Daridorexant 50 mg | 55 | Participants | ||
| Total no. of Subjects With at Least One TEAE | Placebo | 45 | Participants | ||
| Total no. of Subjects With at Least One TEAE | ExPlacebo / Daridorexant 25 mg | 48 | Participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daridorexant 10 mg | 142 | |
| Overall Study | STARTED | Daridorexant 25 mg | 268 | |
| Overall Study | STARTED | Daridorexant 50 mg | 137 | |
| Overall Study | STARTED | Placebo | 128 | |
| Overall Study | STARTED | ExPlacebo/Daridorexant 25 mg | 126 | |
| Overall Study | COMPLETED | Daridorexant 10 mg | 99 | |
| Overall Study | COMPLETED | Daridorexant 25 mg | 190 | |
| Overall Study | COMPLETED | Daridorexant 50 mg | 93 | |
| Overall Study | COMPLETED | Placebo | 78 | |
| Overall Study | COMPLETED | ExPlacebo/Daridorexant 25 mg | 90 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events175
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Daridorexant 10 mg | 7 | 142 | 10 |
| other | Nasopharyngitis | Infections and infestations | Daridorexant 25 mg | 15 | 268 | 16 |
| other | Nasopharyngitis | Infections and infestations | Daridorexant 50 mg | 12 | 137 | 13 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 128 | 6 |
| other | Nasopharyngitis | Infections and infestations | Ex-Placebo Daridorexant 25 mg | 11 | 126 | 11 |
| serious | Aortic valve disease mixed | Cardiac disorders | Daridorexant 10 mg | 0 | 142 | 0 |
| serious | Aortic valve disease mixed | Cardiac disorders | Daridorexant 25 mg | 0 | 268 | 0 |
| serious | Aortic valve disease mixed | Cardiac disorders | Daridorexant 50 mg | 0 | 137 | 0 |
| serious | Aortic valve disease mixed | Cardiac disorders | Placebo | 0 | 128 | 0 |
| serious | Aortic valve disease mixed | Cardiac disorders | Ex-Placebo Daridorexant 25 mg | 1 | 126 | 1 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daridorexant 10 mg | 1 | 142 |
| Total, all-cause mortality | Daridorexant 25 mg | 1 | 268 |
| Total, all-cause mortality | Daridorexant 50 mg | 0 | 137 |
| Total, all-cause mortality | Placebo | 0 | 128 |
| Total, all-cause mortality | Ex-Placebo Daridorexant 25 mg | 0 | 126 |
| Total, other adverse events | Daridorexant 10 mg | 7 | 142 |
| Total, other adverse events | Daridorexant 25 mg | 15 | 268 |
| Total, other adverse events | Daridorexant 50 mg | 12 | 137 |
| Total, other adverse events | Placebo | 6 | 128 |
| Total, other adverse events | Ex-Placebo Daridorexant 25 mg | 11 | 126 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03679884
GET https://conductscience.org/api/trials/v1/NCT03679884/events?page=2