CLINICAL TRIALS PROFILE FOR SUVOREXANT
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All Clinical Trials for SUVOREXANT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00792298 ↗ | Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) | Completed | Merck Sharp & Dohme Corp. | Phase 2 | 2008-11-05 | A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia. |
| NCT01021813 ↗ | A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2009-12-10 | This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase. The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal. |
| NCT01043926 ↗ | Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017) | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 2010-02-22 | This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants. |
| NCT01059851 ↗ | Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED) | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 2010-05-24 | This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired renal function and in healthy participants. |
| NCT01097616 ↗ | Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2010-05-05 | This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase. |
| NCT01097629 ↗ | Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2010-05-03 | This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. |
| NCT01293006 ↗ | Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032) | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 2011-03-25 | This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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