A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.
Quantum Clinical Trials
Miami Beach, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Change From Baseline to Week 4 in sTST
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).
Time frame: From baseline to Week 4 per treatment period.
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Encore Medical Research of Weston
Weston, Florida, United States
Ochsner LSU Health Shreveport-Regional Urology
Shreveport, Louisiana, United States
Accellacare Research of Cary
Cary, North Carolina, United States
Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio
Aachen, Germany
ASR Advanced Sleep Research GmBH
Berlin, Germany
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Germany
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
...and 6 more locations