Health Condition 1: null- hypertension
Conditions
Interventions
Intervention1: Fixed Dose Combination of S-Amlodipine2.5/5 mg,Olmesartan 40 mg and Hydrochlorothiazide 12.5/25 mg tablet: Low Dose - Fixed Dose Combination of S-Amlodipine 2.5mg,Olmesartan 40 mg and H
Sponsors
Emcure Pharmaceuticals Ltd Pune
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients between 18-65 years of age, Subjects diagnosed with essential hypertension not controlled on monotherapy or two drug therapy or newly diagnosed Stage II hypertensives, Subject willing to give written informed consent and willing to comply with study protocol
Exclusion criteria
Exclusion criteria: Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or calcium channel blockers or angiotensin receptor blockers or thiazide diuretic, Subjects with history of secondary or malignant hypertension, Patients with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Patients with evidence of any cardiac arrhythmia on ECG, Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception, Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug, Patients with 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 |
|---|---|
| Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline at 12 weeks of therapyTimepoint: Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline at 12 weeks of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance to therapyTimepoint: After 4, 8 and 12 weeks of therapy;Mean reduction in heart rate compared to baselineTimepoint: After 4, 8 and 12 weeks of therapy;Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baselineTimepoint: After 4, 8 and 12 weeks of thearapy;Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigatorTimepoint: After 4, 8 and 12 weeks of therapy;Subjectâ??s as well as Physicianâ??s global assessment about the tolerability of the drug Timepoint: After 12 weeks of therapy | — |
Countries
India
Contacts
Public ContactDr Anand V Tendulkar
Outcome results
None listed