Health Condition 1: null- newly diagnosed Grade 1 Essential Hypertension
Conditions
Interventions
Intervention1: Azilsartan: Tablet Azilsartan 40 mg, One tablet of test or control drug once a day, Oral for 8 weeks
Control Intervention1: Olmesartan: Tablet Olmesartan 20 mg, One tablet of test or co
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients with duly filled in ICFs [Informed Consent Forms]. 2. Ages: Eligible For Study: 18-75 Years. 3. Genders eligible for study: Both. 4. Patients with newly diagnosed Grade 1 essential hypertension 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. Patients with 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. Patients unwilling to sign on ICF. 2. Patients with known hypersensitivity to the study medications. 3. Patients who is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: antihypertensive agents, Other agents that alter blood pressure, including: tricyclic antidepressants, monoamine oxidase inhibitors, phenothiazines, lithium, Phosphodiesterase type 5 inhibitors, diet medications, amphetamines or their derivatives. 4. Patients who have chronically used: common cold medications or nonsteroidal anti-inflammatory drugs, including aspirin greater than 325 mg per day or cyclooxygenase-2 inhibitors, systemic use of corticosteroids, thiazolidinediones, atypical antipsychotic agents, insulin. 5. Patients who are hypersensitive to angiotensin II receptor blockers. 6. Patients with history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 7. Patients with clinically significant cardiac conduction defects (eg, third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial flutter). 8. Patients with hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 9. Patients with secondary hypertension of any etiology. 10. Patients who are noncompliant (less than 70% or greater than 130%) with study medication during Placebo Run-In Period. 11. Patients with severe renal dysfunction or disease (based on calculated creatinine clearance less than30 mL/min/1.73 m2) at Screening. 12. Patients with known or suspected unilateral or bilateral renal artery stenosis. 13. Patients with history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within the past 2 years. 14. Patients with 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 subjects with basal cell or stage I squamous cell carcinoma of the skin). 15. Patients with type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening. 16. Patients with alanine aminotransferase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening. 17. Patients with hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening. 18. Patients with upper arm circumference less than 24 cm or greater than 42 cm. 19. Patients who work night (3rd) shift (defined as 11 PM to 7 AM). 20. Patients currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening. 21. Patients with any other serious disease or condition at Screening (or Randomization) that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol. 22. Patients who are randomized in a previous azilsartan medoxom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end point will be a change from baseline to Week 8 in the 24-hour mean systolic blood pressureTimepoint: Basline, Day 14, Day 28, Day 42, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot Study â?¢ Change from baseline to day 5 in trough clinic sitting systolic blood pressure â?¢ Change from baseline to day 5 in trough clinic sitting diastolic blood pressure. â?¢ Proportion of subjects who achieve both a clinic Diastolic and Systolic Blood Pressure Response Clinical trial â?¢ Change from baseline to week 8 in Diastolic and Systolic Blood Pressure. â?¢ Proportion of subjects who achieve both a clinic Diastolic and Systolic Blood Pressure ResponseTimepoint: Baseline, Day 56 | — |
Countries
India
Contacts
Public ContactDr Manjusha Patankar
Clinical Medicine Infomatics India Pvt. Ltd.
Outcome results
None listed