| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere |
NCT05597020: A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia |
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| Completed | 4 | 60 | Europe, US | Daridorexant, Placebo | Idorsia Pharmaceuticals Ltd. | Insomnia Disorder, Nocturia | 04/24 | 04/24 | | |
DARIDOR-ALZ, NCT05924425: Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease |
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| Recruiting | 4 | 62 | Europe | Daridorexant 50 mg, Placebo, Polysomnography, Neuropsychological assessment, Questionnaires on sleep and behavioural problems, Actimetrics, 24-hour Ambulatory Blood Pressure Monitoring (ABPM, Biomarker assay | University Hospital, Montpellier, Idorsia Pharmaceuticals Ltd. | Alzheimer Disease, Insomnia Disorder, Sleep | 05/26 | 03/27 | | |
NCT06010693: A Study of Daridorexant in Chinese Patients With Insomnia Disorder |
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| Completed | 3 | 206 | RoW | Daridorexant, Placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | Insomnia Disorder | 04/24 | 05/24 | | |
NCT06630390: Daridorexant to Prevent Delirium After Heart Surgery |
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| Enrolling by invitation | 2 | 12 | US | Daridorexant 50 mg, Placebo | University of Rochester | POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINE | 01/25 | 03/25 | | |
NCT05423717 / 2021-003867-87: Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder |
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| Recruiting | 2 | 150 | Europe, US | Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo | Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd | Insomnia | 03/25 | 04/25 | | |
NCT05422612: Department of Defense PTSD Adaptive Platform Trial - Master Protocol |
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| Recruiting | 2 | 600 | US | Intervention A Fluoxetine Hydrochloride (HCl), Intervention A Placebo, Intervention B Vilazodone Hydrochloride (HCl), Intervention B Placebo, Intervention C Daridorexant, Intervention C Placebo | Global Coalition for Adaptive Research, U.S. Army Medical Research and Development Command, PPD DEVELOPMENT, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline | Post Traumatic Stress Disorder | 03/26 | 09/26 | | |
NCT05948540: Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant |
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| Active, not recruiting | 2 | 200 | US | Intervention C Daridorexant, Intervention C Placebo | Global Coalition for Adaptive Research, U.S. Army Medical Research and Development Command, PPD DEVELOPMENT, LP, Berry Consultants, Idorsia Pharmaceuticals Ltd., Cambridge Cognition Ltd, Citeline | Post Traumatic Stress Disorder | 03/26 | 09/26 | | |
NCT03686995: Study to Evaluate the PK of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment |
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| Not yet recruiting | 1 | 32 | Europe | ACT-541468 | University Hospital, Basel, Switzerland, Idorsia Pharmaceuticals Ltd. | Hepatic Impairment | 06/19 | 06/19 | | |
NCT05458193: A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep |
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| Completed | 1 | 20 | Europe | Daridorexant, ACT-541468, Placebo | Idorsia Pharmaceuticals Ltd. | Obstructive Sleep Apnea of Adult | 02/23 | 02/23 | | |
NCT05702177: A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented |
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| Completed | 1 | 36 | Europe | Daridorexant 25 mg, Quviviq, Daridorexant 50 mg, Placebo | Idorsia Pharmaceuticals Ltd. | Healthy | 04/23 | 04/23 | | |
NCT05632393: A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women |
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| Completed | 1 | 10 | US | Daridorexant | Idorsia Pharmaceuticals Ltd. | Healthy | 04/23 | 04/23 | | |
NCT05877222: A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants |
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| Completed | 1 | 38 | US | Daridorexant 10 mg, Daridorexant 25 mg | Idorsia Pharmaceuticals Ltd. | Healthy | 08/23 | 08/23 | | |
NCT06326723: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects |
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| Completed | 1 | 32 | RoW | Daridorexant | Jiangsu Simcere Pharmaceutical Co., Ltd. | Healthy Volunteer | 12/23 | 02/24 | | |
NCT06393504: Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) |
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| Active, not recruiting | N/A | 2095 | US | Daridorexant, QUVIVIQ, Non-orexin receptor antagonist insomnia medication, No insomnia medication | Idorsia Pharmaceuticals Ltd., Carelon Research | Insomnia Disorder | 04/28 | 04/28 | | |
NCT06311864: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada |
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| Recruiting | N/A | 100 | Canada | Daridorexant 50 mg, QUVIVIQ | PeriPharm, Idorsia Pharmaceuticals Ltd. | Insomnia | 12/24 | 12/24 | | |
NCT06498128: Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ® |
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| Recruiting | N/A | 785 | Europe, Canada, US | Daridorexant, QUVIVIQ, Non-orexin receptor antagonist medications for insomnia, No insomnia medication | Idorsia Pharmaceuticals Ltd., Iqvia Pty Ltd | Insomnia | 03/33 | 03/33 | | |
