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Effect of drug intervention on hypertensive patients

Phase 4
Conditions
Health Condition 1: I10- Essential (primary) hypertension
Registration Number
CTRI/2019/11/021961
Lead Sponsor
All India Institute of medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients of either sex aged between 30 â?? 65 years.

Hypertensive patients who had not achieved target BP levels as defined by JNC 8 with monotherapy for at least one month

Willing to participate by giving written informed consent.

Hypertensive patients with other comorbidities

Exclusion Criteria

Patients diagnosed with secondary hypertension

Patients of hypertensive emergency and hypertensive urgency

Presence of hyperkalaemia (potassium level >= 5.5 mEq)

Pregnant and lactating women

•Patient history of allergic to Azilsartan, Telmisartan, and Amlodipine

Any serious hepatic, cardiovascular, renal or pulmonary condition which may prevent participation in the study

Any drug having an adverse interaction with azilsartan, telmisartan, and amlodipine in term of safety and efficacy.

Patients diagnosed with Type 1 DM.

Type 2 Diabetic patients with HbA1c > 8.5%

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate and compare the response rate of azilsartan and amlodipine against telmisartan and amlodipine after 12 weeks of therapy <br/ ><br> <br/ ><br>Timepoint: To evaluate and compare the response rate of azilsartan and amlodipine against telmisartan and amlodipine after 12 weeks of therapy <br/ ><br> <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
To evaluate and compare the change in blood pressure from baseline at 12 weeks in both the groups <br/ ><br>To evaluate and compare the changes in NT- pro BNP level, cystatin c & highly sensitive Troponin I(hsTnI) from baseline at 12 weeks <br/ ><br>To evaluate and compare the changes in BUN, serum urea,creatinine from baseline at 12 weeks <br/ ><br>To compare adverse effects of the two treatment population <br/ ><br> <br/ ><br>Timepoint: 12 weeks
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