Comparison of efficacy and safety of amlodipine versus lercanidipine.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2018/10/016069
- Lead Sponsor
- DrSSneha Aishwarya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects having blood pressure: SBP >= 140 and 179 mmHg and diastolic between 90 and 109 mmHg.
2. Subjects with normal serum creatinine, SGOT, SGPT at the beginning of the study.
3.Subjects fulfilling the eligibility criteria who understood the study related procedures and would be available during the treatment period and who are willing to participate in the study by voluntarily signing the informed consent form
1.Subjects not willing to participate in the study.
2. Subjects having systolic greater than 180mm Hg and diastolic greater than 110 mm Hg.
3 . Subjects with Diabetes
a)obstructive biliary disease
b)cholestasis
c)hepatic impairment
d)renal impairment
e)Aortic stenosis
f)unstable angina
g)uncontrolled heart failure
h)MI within one month of attack
i)pregnant and lactating women
j)female patients of child bearing age group not using approved contraception
k)Non smoker
l)Non alcoholic
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in blood pressure from baseline after 12 weeks. <br/ ><br>Amlodipine 5mg/day versus Lercanidipine 10mg/day <br/ ><br>Timepoint: 4weeks <br/ ><br>8weeks <br/ ><br>12weeks <br/ ><br>14weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method To analyse the adverse drug reactions and to compare the blood parameters like To compare the change in blood pressure from baseline after 12 weeks. <br/ ><br>Amlodipine 5mg/day versus Lercanidipine 10mg/day <br/ ><br>serum creatine, SGOT, SGPT at the end of the study. <br/ ><br> Amlodipine 5mg/day versus Lercanidipine 10mg/day <br/ ><br>Timepoint: Three months