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Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

NCT03679884 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2022-03-02

Study results available
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Summary

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

Conditions

  • Insomnia Disorder

Interventions

DRUG

Daridorexant 10 mg

Daridorexant 10 mg film-coated tablets

DRUG

Daridorexant 25 mg

Daridorexant 25 mg film-coated tablets

DRUG

Daridorexant 50 mg

Daridorexant 50 mg film-coated tablets

DRUG

Placebo

Matching placebo film-coated tablets

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2021-02-22
Completion
2021-02-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03679884 on ClinicalTrials.gov