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.
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.
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.
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