Clinical Study to assess the efficacy and safety of fixed dose combination of S-Amlodipine besilate, Olmesartan medoxomil and Hydrochlorothiazide tablets in hypertension
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 18
- Primary Endpoint
- 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
Study Overview
Brief Summary
This multicentric, open label, Randomized, Comparative clinical trial is planned to assess efficacy and safety of FDC of S - Amlodipine besilate (2.5/5 mg), Hydrochlorothiazide 12.5/25 mg and Olmesartan 40 mg Tablet. Patient satisfying inclusion and exclusion criteria will receive either test or Reference drug as per Randomization.In test group at screening visit patient will start with FDC of S-Amlodipine 2.5 mg, Hydrocholorothiazide 12.5 mg and Olmesartan 40mg one tablet once daily for first 4 weeks and in subsequent visit if BP >140/90 mm of Hg then dose of FDC will increased upto S-Amlodipine 5mg + Olmesartan 40 mg + Hydrochlorothiazide 25 mg once daily upto 12 weeks. If dose doesnot modified same dose will continue.In Reference group initially patient will start with FDC of Amlodipine 25mg with Hydrochlorothiazide 12.5 mg one tablet once daily with Olmesartan 40 mg one tablet once daily. In subsequent visit if BP>140/90 mm of Hg then this dose will increase upto FDC of Amlodipine 25mg + Hydrocholorthiazide 12.5 mg two tablets once daily along with Olmesartan 40 mg one tablet once daily.Baseline laboratory investigations will be done. Patients will be evaluated for efficacy and safety variables after 4, 8 and 12 weeks of therapy. Same laboratory investigations will be repeated after 12 weeks of therapy except ECG.The study duration is of 12 weeks
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
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
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 therapy
Secondary Outcomes
- Compliance to therapy(After 4, 8 and 12 weeks of therapy)
- Mean reduction in heart rate compared to baseline(After 4, 8 and 12 weeks of therapy)
- Subject’s as well as Physician’s global assessment about the tolerability of the drug
- Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator(After 4, 8 and 12 weeks of therapy)
- Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline(After 4, 8 and 12 weeks of thearapy)