An open label single arm non-comparative study to assess effectiveness and safety ofZolpidem Tartrate in patients of insomnia with hypertension

Dr Rajiv D Karnik0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Healthy adult patients (both male and female) who are 18 to <65 years of age.
•2. Must experience sleep disturbances (difficulty in sleep initiation or middle of the night
•awakening or early morning awakening or poor quality of sleep) at least 3 nights/week,
•based on historical data.
•3. Insomnia Severity Index score of >=8 at screening
•4. Patients with a clinical diagnosis of Hypertension (at least one year prior to screening).
•5. Patient willing to sign informed consent form.

•1. Currently using prescription and non-prescription sedative drugs given for more than
•2 days for the purpose of sleep disturbances or to relieve jet lag with the last 28 days
•proceeding to enrollment.
•2. Shift work or requirement for a regular change in sleep schedule by at least six hours
•with in the previous 28 days.
•3. Evidence of any medical condition as revealed by history, physical examination or
•laboratory assessment which may interfere with administration or assessment of study
•4. Current alcohol or drug abuse
•5. Patients viewed by the investigator as not being able to complete the study.
•6. History of obstructive sleep apnoea or restless leg syndrome.
•7. History of myasthenia gravis.
•8. History of hepatic insufficiency.
•9. History of respiratory depression.
•10. Patients with a known history of hypersensitivity to Zolpidem tartrate or any of the inactive ingredients.

发起方

Dr Rajiv D Karnik