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 A - Phase III Safety and Efficacy Study in Primary Insomnia Patients-Study A

Merck Sharp & Dohme Corp.0 个研究点目标入组 960 人开始时间: 2010年6月22日最近更新: 2012年9月25日

适应症

试验速览

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•Patient is/reports:
•1. Age =18 yrs on the day of signing informed consent.
•2. Diagnosed with primary insomnia.
•3. In good physical and mental health.
•4. If = 65 yrs old, scores = 25 on the Mini Mental State Exam.
•5. A female who is of reproductive potential, has a negative serum pregnancy test, and agrees to use contraception.
•6. Difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria).
•7. Spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1.
•8. Regular bedtime between 9pm-1am.
•9. Willing to refrain from napping while in study.
•10. Able to read, understand and complete questionnaires and all diaries.
•11. Willing to limit alcohol, caffeine, and nicotine consumption.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient is/reports:
•1. A female who is pregnant and breastfeeding at Prestudy visit, or expecting to conceive while in study.
•2. A history or diagnosis of sleeping disorders.
•3. Difficulty sleeping due to a medical condition.
•4. A history of neurological disorders.
•5. A history of any clinically severe psychological disorder or current psychiatric disorder that requires a prohibited medication.
•6. Ongoing depression.
•7. A history of substance abuse or dependence.
•8. A history or current evidence of a clinically significant cardiovascular disorder or clinically significant ECG at Prestudy Visit.
•9. Taking certain prohibited medications.
•10. Consuming the equivalent of >15 cigarettes a day.
•11. A history of malignancy = 5 years prior to signing informed consent, with the exception of basal cell or squamous cell skin cancer.
•12. Morbidly obese.
•13. Was previously randomized in another investigational study of MK-4305.
•14. Currently participating or has participated in a clinical study within 30 days of signing informed consent.

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