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NCT05597020 · ClinicalTrials.gov registry record · Phase 4
A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
A Phase 4 study of Nocturia and Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 16
- Study locations
NCT05597020: Completed Phase 4 study of Nocturia and Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
NCT05597020 is a Phase 4 study of Nocturia and Insomnia Disorder that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 60 participants, below the 310-participant average among 9 other Nocturia trials with a reported enrollment target (81% lower). The trial reports 16 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05597020, a Phase 4 study of Nocturia and Insomnia Disorder, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 16
- Study locations
Study Summary
A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
Primary Outcome
Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Daridorexant
Study Locations (16)
Other
- Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio - Aachen
- ASR Advanced Sleep Research GmBH - Berlin
- SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH - Schwerin
- Complejo Hospitalario Universitario A Coruña - A Coruña
- Hospital del Mar - Barcelona
- UROCLINICA Barcelona - Barcelona
- Hospital Universitario Puerta del Mar (HUPM) - Cadiz
- Hospital Universitario Fundación Jiménez Díaz - Madrid
- Hospital Universitario La Paz - Madrid
- Hospital Universitario Central de Asturias - Oviedo
- Hospitalario Universitario de Canarias - San Cristóbal de La Laguna
Florida
- Quantum Clinical Trials - Miami Beach
- Clinical Research Center of Florida - Pompano Beach
- Encore Medical Research of Weston - Weston
Louisiana
- Ochsner LSU Health Shreveport-Regional Urology - Shreveport
North Carolina
- Accellacare Research of Cary - Cary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-02-16 |
| Est. Completion | 2024-04-18 |
| Phase | Phase 4 |
What the finished NCT05597020 record still lists
NCT05597020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 310-participant average among 9 other Nocturia trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Nocturia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05597020 lists 16 locations in 4 states (Other, Florida, Louisiana).
Frequently Asked Questions
What is clinical trial NCT05597020 about?
NCT05597020 is a clinical study titled "A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia". A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
What is the current status of trial NCT05597020?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2023-02-16. Estimated completion is 2024-04-18.
What conditions does trial NCT05597020 study?
This clinical trial studies the following conditions: Nocturia, Insomnia Disorder.
What interventions are being tested in trial NCT05597020?
The interventions under investigation include: Placebo (DRUG), Daridorexant (DRUG).
Who is sponsoring clinical trial NCT05597020?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05597020 being conducted?
This trial has 16 study locations across Florida, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05597020's enrollment target sits among peer trials
60 7th of 9 higher than 2 of 9 other Nocturia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nocturia 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.
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