Comparison of efficacy and safety of amlodipine versus lercanidipine.

A Randomised Open Label Parallel Group Comparitive Study To Evaluate The Efficacy And Safety OF Amlodipine Versus Lercanidipine In Mild To MOderate Hypertensive Subjects.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/016069

Enrollment

Registered

2018-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: SGOT,SGPT ,SERUM CREATININE: Blood investigatin like SGOT,SGPT ,SERUM CREATININE will be taken at the 1st visit and at the 4th visit Control Intervention1: amlodipine versus lercanidipi

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the change in blood pressure from baseline after 12 weeks. Amlodipine 5mg/day versus Lercanidipine 10mg/day Timepoint: 4weeks 8weeks 12weeks 14weeks	—

Secondary

Measure	Time frame
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. Amlodipine 5mg/day versus Lercanidipine 10mg/day serum creatine, SGOT, SGPT at the end of the study. Amlodipine 5mg/day versus Lercanidipine 10mg/day Timepoint: Three months	—

Countries

India

Contacts

Public ContactSneha Aishwarya S

Sri Ramachandra Medical College and research Institute.

drgowri16@yahoo.com9444399062

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026