Effect of drug intervention on hypertensive patients

Comparison of efficacy and safety of azilsartan and amlodipine versus telmisartan and amlodipine in hypertensive patients-A non-inferiority study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/021961

Enrollment

100

Registered

2019-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Azilsartan 40mg and amlodipine 5mg daily for 12 weeks in the morning: Azilsartan 40mg and amlodipine 5mg daily for 12 weeks in the morning Control Intervention1: Telmisartan 40 mg and

Eligibility

Inclusion criteria

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

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%

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the response rate of azilsartan and amlodipine against telmisartan and amlodipine after 12 weeks of therapy Timepoint: To evaluate and compare the response rate of azilsartan and amlodipine against telmisartan and amlodipine after 12 weeks of therapy	—

Secondary

Measure	Time frame
To evaluate and compare the change in blood pressure from baseline at 12 weeks in both the groups To evaluate and compare the changes in NT- pro BNP level, cystatin c & highly sensitive Troponin I(hsTnI) from baseline at 12 weeks To evaluate and compare the changes in BUN, serum urea,creatinine from baseline at 12 weeks To compare adverse effects of the two treatment population Timepoint: 12 weeks	—

Measure

Time frame

To evaluate and compare the change in blood pressure from baseline at 12 weeks in both the groups To evaluate and compare the changes in NT- pro BNP level, cystatin c & highly sensitive Troponin I(hsTnI) from baseline at 12 weeks To evaluate and compare the changes in BUN, serum urea,creatinine from baseline at 12 weeks To compare adverse effects of the two treatment population Timepoint: 12 weeks

—

Countries

India

Contacts

Public ContactDr Ashish Dash

All India Institute of Medical Sciences

pharm_bikash@aiimsbhubaneswar.edu.in7750968735

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026