A clinical study to check the effectiveness and safety of the medicine Zolpidem Tartrate in the patients of Insomnia with hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: G470- Insomnia
- Registration Number
- CTRI/2018/12/016688
- Lead Sponsor
- Dr Rajiv D Karnik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
medication
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the change in Insomnia severity index (ISI) ScoreTimepoint: Baseline visit to Day 21 visit
- Secondary Outcome Measures
Name Time Method To measure the change in HRQoL ScoreTimepoint: Baseline visit to Day 21 visit