To evaluate the effect of Telmisartan 40mg against Cilnidipine 10mg tablet administrated to hypertensive patients using Ambulatory Blood pressure monitoring.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2021/08/035858
- Lead Sponsor
- Dr Rahul Sawant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Patients aged 18 years to 60 years willing to provide a signed informed consent document.
2. Newly diagnosed stage I hypertension defined as a mean seated SBP >= 140 & DBP >= 90 mmHg measured by manual cuff sphygmomanometer in OPD set up requiring initiation of antihypertensive medication.
3. Patients requiring initiation of antihypertensive treatment with single-drug therapy.
1. Presence of any clinically relevant disease/disorder (e.g. severe hepatic impairment, chronic renal failure, thromboembolic disorders, coronary artery or cerebrovascular diseases, uncontrolled diabetes, uncontrolled thyroid disorder etc.)
b. Patients of T2DM with diagnosis of T2DM more than 2 year back.
2. Patients of T1DM
3. Patients, in opinion of investigators, requiring initiation of treatment with initial combination therapy
4. Surgical or medical condition that, in the judgment of the Investigator, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
5. Presence or history of secondary or malignant hypertension.
6. Any known cardiac disease/disorder in which any of the study medication is contra-indicated.
7. Current or recent substance abuse, including alcohol.
8. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
9. Participation in any experimental drug study within 60 days before screening.
10. Breast feeding or pregnant females or Females with child-bearing potential who do not follow adequate contraceptive measures.
11. Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blocker, clonidine, aliskiren.
12. Subjects having intolerance,hypersensitivity or any other contraindication to any of the Investigational products.
13. History of HIV, Hepatitis B and Hepatitis C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes from baseline in mean diastolic and systolic blood pressure during the last 6 hours of a 24-hour dosing interval measured by ambulatory blood pressure monitoring (ABPM) .Timepoint: Changes from baseline in mean diastolic and systolic blood pressure during the last 6 hours of a 24-hour dosing interval measured by ambulatory blood pressure monitoring (ABPM) [ Time Frame: Day 0 to Day 56 ].
- Secondary Outcome Measures
Name Time Method Changes from baseline to day 56 in the mean ABPM for SBP and DBP during the 24-h dosing interval, the morning (0600 to 1159 hours), daytime (0600 to 2159 hours) and night time (2200 to 0559 hours) BP. a. (The 24-h mean ABPM was defined as the average of the hourly mean ABPM values for 24 h) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1. Changes from baseline to day 56 in the mean ABPM for SBP and DBP during the 24-h dosing interval, the morning (0600 to 1159 hours), daytime (0600 to 2159 hours) and night time (2200 to 0559 hours) BP. (The 24-h mean ABPM was defined as the average of the hourly mean ABPM values for 24 h)