A randomized, double blind, controlled clinical trial of S-Amlodipine versus conventional Amlodipine, to compare the incidence of leg edema and antihypertensive efficacy in patients with hypertensio

Not Applicable

Completed

• Conditions: Hypertension, leg oedema

• Registration Number: SLCTR/2013/006
• Lead Sponsor: Emcure Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

30-64 years of age • Diagnosed essential hypertension with either systolic BP > 140mmHg or diastolic BP > 90 mmHg or both while in the seated position • On beta blockers and ACE inhibitor /Angiotensin receptor blocker for at least 4 weeks • Consenting and willing to comply with study protocol

Exclusion Criteria

Known hypersensitivity to amlodipine, calcium channel blockers or to any ingredients of the test/reference medication • Patients on calcium channel blockers or antihypertensive therapy other than ACE inhibitors or Angiotensin receptor blockers • Secondary hypertention • Clinical diagnosis of resistant or malignant hypertension • History of myocardial infarction or congestive cardiac failure • PTCA, CABG, cerebrovascular accident, or TIA in last 6 months • Diagnosed cardiac arrhythmias and/or any other abnormality on ECG • Significant respiratory /liver/ kidney/neurological diseases/ coagulation disorders • Metabolic or endocrine disorders (except Type 2 diabetes mellitus • Type 2 diabetes mellitus taking insulin or oral hypoglycemic drugs other than metformin or sulfonylurea or patients on more than one sulfonylurea • Pregnant and lactating women or women in the reproductive age group not practicing effective means of contraception. • Known alcohol or drug abuse
Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified