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
- Conditions
- Hypertension, leg oedema
- Registration Number
- SLCTR/2013/006
- Lead Sponsor
- Emcure Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
- Primary Outcome Measures
Name Time Method Proportion of patients having peripheral edema (pitting oedema), not attributable to any concomitant drug, as assessed clinically at the following anatomical points: proximal to medial malleolus, behind medial malleolus and dorsum of the foot. [At baseline and at 16 weeks (end of therapy)]<br>
- Secondary Outcome Measures
Name Time Method