A phase-III clinical trial to study the effects of Azilsartan in Indian patients of hypertension.

Phase 3

Completed

• Conditions: Elevated blood-pressure reading, without diagnosis of hypertension, Mild to moderate Essential Hypertension,

• Registration Number: CTRI/2014/08/004840
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of Azilsartan Test product (Hetero) and Reference product in mild to moderate essential hypertension. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The primary objective is to study the efficacy of azilsartan in Indian adult patients of essential hypertension. The secondary objectives are to evaluate the tolerability and safety of azilsartan in Indian adult patients of essential hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-08
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 2.Patients with mild to moderate essential hypertension (defined as sitting trough clinic systolic blood pressure between 140 mmHg and 180 mmHg inclusive at Day minus 1 and 24-hour mean systolic blood pressure between 130 mmHg and 170 mmHg inclusive at Day 1).
• Sitting trough clinic diastolic blood pressure <114mmHg at Day minus 1.
• 3.Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study 4.Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator 5.Willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit.
• If the patient is on amlodipine prior to screening, the patient is willing to discontinue this medication at Screening Day minus 28.

Exclusion Criteria

• 1.Required to take or continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
• 2.Hypersensitive to angiotensin II receptor blockers.
• Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
• 4.Recent history (within the last 6 months) of myocardial infarction, Patients with NYHA class III and IV heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack (Stable coronary artery disease (CAD) patients more than 3 months duration with or without angioplasty can be included).
• 5.Clinically significant cardiac conduction defects (e.g., 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter).
• 6.Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
• 7.Secondary hypertension of any etiology.
• 8.Non-compliant with the study medication or any study related procedures 9.Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30mL per min/1.73m2) at screening.
• 10.Known or suspected unilateral or bilateral renal artery stenosis.
• 11.History of drug or alcohol abuse within the past 2 years.
• 12.Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
• (This criterion does not apply to those patients with basal cell or Stage 1 squamous cell carcinoma of the skin).
• 13.Hyperkalemia as defined by the central laboratory normal reference range at screening.
• 14.Upper arm circumference less than 24 cm or greater than 42 cm.
• 15.Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening.
• 16.Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
• 17.Any other serious disease or condition at screening (or randomization) that would compromise patient safety, might affect life expectancy, or make it difficult to successfully manage and follow the patient according to the protocol.
• 18.Participated and treated in a previous study with azilsartan or a sartan, ACE inhibitors, and ANP & BNP inhibitors, within 30 days prior to randomization.
• 19.Patients with any other serious concurrent medical or surgical illness or malignancy 20.Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE.
• 21.Any other disease state which could interfere with trial participation or trial evaluation as per investigator’s discretion 22.Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period 23.The physician is of the opinion that changing a patient’s trial medications would put the patient at risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure	Start to end of week 6 of study treatments

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
Change from Baseline in the 24-hour Mean Systolic and Diastolic Blood Pressure measured by Ambulatory Blood Pressure Monitoring

Trial Locations

Locations (5)

Institute of Postgraduate Medical Education & Research; 🇮🇳 Kolkata, WEST BENGAL, India

Mediciti Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Osmania General Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Rajiv Gandhi Institute of Medical Sciences; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Sir Gangaram Hospital; 🇮🇳 Delhi, DELHI, India

Institute of Postgraduate Medical Education & Research

🇮🇳Kolkata, WEST BENGAL, India

DrManojit LodhaMD DM

Principal investigator

033-22235181

manojit.lodha@gmail.com