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Last Updated: October 24, 2020

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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 2008-11-01 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 2009-12-01 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 2010-02-01 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 2010-05-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Suvorexant

Condition Name

Condition Name for Suvorexant
Intervention Trials
Insomnia 17
Sleep Disturbance 3
Primary Insomnia 3
Opioid-use Disorder 2
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Condition MeSH

Condition MeSH for Suvorexant
Intervention Trials
Sleep Initiation and Maintenance Disorders 20
Parasomnias 7
Sleep Wake Disorders 7
Dyssomnias 5
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Clinical Trial Locations for Suvorexant

Trials by Country

Trials by Country for Suvorexant
Location Trials
United States 38
Canada 2
Korea, Republic of 1
Lebanon 1
Italy 1
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Trials by US State

Trials by US State for Suvorexant
Location Trials
California 6
Maryland 4
Texas 3
Michigan 3
Pennsylvania 2
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Clinical Trial Progress for Suvorexant

Clinical Trial Phase

Clinical Trial Phase for Suvorexant
Clinical Trial Phase Trials
Phase 4 16
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Suvorexant
Clinical Trial Phase Trials
Not yet recruiting 20
Recruiting 13
Completed 8
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Clinical Trial Sponsors for Suvorexant

Sponsor Name

Sponsor Name for Suvorexant
Sponsor Trials
Merck Sharp & Dohme Corp. 17
University of California, San Francisco 2
Howard University 2
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Sponsor Type

Sponsor Type for Suvorexant
Sponsor Trials
Other 39
Industry 20
U.S. Fed 5
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