Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: null- Essential Hypertension
Conditions
Interventions
Intervention1: A. Azilsartan 40 mg plus Chlorthalidone 12.5 mg Tablets
B. Azilsartan 40 mg plus Chlorthalidone 25 mg Tablets: Orally, once daily for 12 weeks
Control Intervention1: A. Olmesartan 20 mg
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients with de novo essential hypertension 2. The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures. 3. Has a mean sitting trough clinic systolic blood pressure = 160 mm Hg and = 190 mm Hg (Stage 2 hypertension) as per Joint National Committee (JNC) VII guidelines. 4. Has a mean sitting trough clinic diastolic blood pressure 5. 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. 6. 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.
Exclusion criteria
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 or thiazide-type diuretics or other sulfonamide-derived compounds. 3. 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). 4. Clinically significant cardiac conduction defects (e.g., 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter). 5. Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 6. Secondary hypertension of any etiology. 7. Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30mL per min/1.73m2) at screening. 8. Known or suspected unilateral or bilateral renal artery stenosis. 9. Hyperkalemia as defined by the central laboratory normal reference range at screening. 10. Poorly controlled diabetes mellitus (HbA1c >8.0%) 11. Patients with anuria 12. Upper arm circumference less than 24 cm or greater than 42 cm. 13. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening. 14. 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). 15. Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE. 16. History of drug or alcohol abuse within the past 2 years. 17. Non-compliant with the study medication or any study related procedures. 18. Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization. 19. 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. 20. Participated and treated in a previous study with azilsartan or a sartan, ACE inhibitors, and ANP & BNP inhibitors, within 30 days prior to randomization. 21. Patients with any other serious concurrent medical or surgical illness or malignancy. 22. Any other disease state which could interfere with trial participation or trial evaluation as per investigator’s discretion 23. 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. 24. The physician is of the opinion that changing a patient’s trial medications would put the patient at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Trough Clinic Sitting Systolic Blood PressureTimepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Trough Clinic Sitting Diastolic Blood PressureTimepoint: 12 Weeks;Change from Baseline in the 24-hour Mean Systolic and Diastolic Blood Pressure measured by Ambulatory Blood Pressure MonitoringTimepoint: 12 Weeks;Percentage of patients reaching =80% compliance to study treatmentTimepoint: 12 Weeks;Percentage of responders at the end of 4 weeks, 8 weeks and 12 weeks of the treatment periodTimepoint: 4, 8 and 12 Weeks;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: 12 Weeks | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Labs Limited
Outcome results
None listed