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A clinical trial to study the effects of two drugs, Azilsartan and Losartan in patients with high blood pressure

To compare the efficacy and safety of Azilsartan versus Losartan in patients of hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027209
Enrollment
100
Registered
2020-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: The group I patients will receive Azilsartan 40-80 mg OD by oral route. The dose will be adjusted according to the severity of hypertension. The therapeutic efficacy of dru

Sponsors

PIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: New patients with hypertension i.e not on any antihypertensive therapy. 2. Adult males and females of age 18 years or more.

Exclusion criteria

Exclusion criteria: 1.Sitting clinic diastolic BP (DBP) >114ââ?¬Æ?mm Hg 2.Patients already on anti-hypertensives. 3.Patients with hypersensitivity to AZL or Losartan. 4.Pregnant/ lactating women/ women planning to conceive. 5.Evidence of severe renal disorder. 6.Patients with hepatic insufficiencies. 7.Patients unwilling or unable to comply with the study proceedings. 8.Patients with severe bradycardia, cardiogenic shock, heart block, sick sinus syndrome, decompensated heart failure, bronchial asthma, hypothyroidism, CVA, CAD. 9.Patients with other co morbidities like hyperthyroidism, anxiety disorders. 10.Patients with refractory hypertension.

Design outcomes

Primary

MeasureTime frame
The end point of the study is attainment of BP 140/90 mmHg for all patients and then maintains it.Timepoint: The SBP will be measured at the end of 24 weeks and compared between the two groups.

Secondary

MeasureTime frame
1. Responders and Non-responders will be identified. Responders- those patients whose clinic SBP falls to 140mm of Hg with maximum dose and/or reduced by ââ?°Â¥20ââ?¬Æ?mm Hg from baseline within one month are classed as responders while those patients whose clinic systolic blood pressure does not fall to 140mm of HG with maximum dose within one month are classed as non-responders.Timepoint: 1 month;Following base line investigations will be carried out at the commencement of treatmentââ?¬â?hemoglobin (Hb), total leucocyte count (TLC), differential leucocyte count (DLC), fasting blood sugar (FBS), Blood Urea, uric acid, Serum Creatinine, serum electrolytes, liver function test (LFT), Lipidogram, echocardiography (ECG) and urine routine examination (R/E). At the end of the treatment the investigations will be repeated and compared with the previous ones.Timepoint: 24 week;Patient acceptance of treatment on three point scale will be recorded at the end of treatment at 24 week. 0--Not acceptable 1-- Accepted with discomfort 2--- Very well accepted Timepoint: 24 week

Countries

India

Contacts

Public ContactBaljit Jassal

Punjab Institute of Medical Sciences

sunilkumarsharma496@gmail.com9815040767

Outcome results

None listed

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