A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study B

Update Il y a 4 ans
Reference: EUCTR2010-018414-69

Woman and Man

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Extract

All Main/Primary objectives are MK-4305 high dose compared to placebo, as measured by change from baseline: Maintenance- 1. Mean subjective total sleep time (sTSTm) at Month 1 2. Wakefulness after persistent sleep onset (WASO) by PSG at Month 1 3. Mean subjective total sleep time (sTSTm) at Month 3 4. Wakefulness after persistent sleep onset (WASO) by PSG at Month 3 Onset- 5. Mean subjective time to sleep onset (sTSOm) at Month 1 6. Latency to onset of persistent sleep (LPS) by PSG at Month 1 7. Mean subjective time to sleep onset (sTSOm) at Month 3 8. Latency to onset of persistent sleep (LPS) by PSG at Month 3 Safety- 9. Safety and tolerability of MK-4305 for up to 3 months of treatment


Inclusion criteria

  • Primary Insomnia