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A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomni...

Update Il y a 4 ans
Reference: EUCTR2008-006018-97

A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia

Woman and Man

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Extract

1. To evaluate the efficacy of MK-4305 compared with placebo in improving sleep efficiency (SE) as measured by polysomnography (PSG) on Night 1 and at the end of 4 weeks of treatment, where SE is defined as 100 times total sleep time (minutes) divided by time in bed (minutes). 2. To evaluate the safety and tolerability of MK-4305.

Inclusion criteria

  • Primary Insomnia

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