Hypertension, leg oedema
Conditions
Interventions
The test medication (S-amlodipine: ASOMEX tablets 2.5 mg / 5 mg [Emcure Pharmaceuticals, India]) and the reference medication (Conventional amlodipine: Amlogard tablets 5 mg /10 mg [ Pfizer –India]) w
Sponsors
Emcure Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate: Subjects showing reduction in systolic blood pressure by >/= 20 mm of Hg and / or diastolic blood pressure by >/= 10 mm or those achieving systolic blood pressure </=140 mm of Hg and diastolic blood pressure </= 90 mm of Hg 2. The following will be assessed monthly a. Systolic, diastolic and mean blood pressure (B.P.) b. Change in pitting oedema scores (combined scores for all 3 points) c. Change in ankle circumference d. Difference in patient assessment questionnaire 3. Subject’s global assessment about the tolerability of the drug 4. Physician’s global assessment about the tolerability of the drug 5. Percentage of the subjects experiencing any drug related adverse event not attributed to any concomitant drug, as evaluated and recorded by the investigator 6. Change in investigational parameters: CBC (Complete Blood Count), LFT (Liver Function test), Lipid profile, FBG (Fasting Blood Glucose), Urine examination and ECG (Electrocardiogram) [1. At the end of therapy 2. Monthly 3. At the end of therapy 4. At the end of therapy 5. At the end of therapy 6. At baseline and at the end of therapy] | — |
Countries
Sri Lanka
Contacts
Public ContactDR. R.A.I. Ekanayake
Consultant Cardiologist
Outcome results
None listed