Health Condition 1: null- Patients with moderate to severe hypertension.
Conditions
Interventions
Intervention1: Fixed dose combination of Azilsartan medoxomil (40 mg) and Chlorthalidone (12.5 mg and 25 mg): Fixed dose combination of Azilsartan medoxomil and Chlorthalidone to be taken once daily f
Sponsors
SYNOKEM Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women between 18-65 years of age (Both are inclusive). 2. Newly diagnosed patients or De novo patients are eligible for study. 3. Patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 4. Patient having moderate to severe systolic hypertension (defined as sitting trough clinic systolic blood pressure is between 160 mmHg and 190 mmHg inclusive at screening visit) 5. Patients with sitting diastolic hypertension (DBP) 6. 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. 7. 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. Clinically significant renal (estimated glomerular filtration rate: 2. Hypersensitive to angiotensin II receptor blockers or diuretics or any ingredient of the formulation. 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 4. Clinically relevant or unstable cardiovascular diseases 5. Type 1 or poorly controlled type 2 diabetes mellitus (HbA1c: � 8%). 6. Pregnant, nursing women or women with childbearing potential not using medically approved means of contraception 7. Patients taking any antihypertensive or concomitant medications known to affect BP. 8. History of drug or alcohol abuse or those who smoke >1 pack of cigarettes per day 9. Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study. 10. Secondary hypertension of any etiology. 11. Subject who have used any investigational drug or device within 30 days or 5 half-lives of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study. 12. Any other disease state which could interfere with trial participation or trial evaluation as per investigator�s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Trough Clinic Sitting Systolic Blood PressureTimepoint: Day 1, Day 28, Day 42 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Trough Clinic Sitting Diastolic Blood PressureTimepoint: Day 1, Day 28, Day 42 and Day 84;Change from Baseline in the 24-hour Mean Systolic and Diastolic Blood Pressure measured by Ambulatory Blood Pressure MonitoringTimepoint: Day 1 and Day 84;Percentage of responders at the end of 12 weeks of the treatment periodTimepoint: Day 28, Day 42 and Day 84 | — |
Countries
India
Contacts
Public ContactMr Sanjib Panda
Ocius Life Sciences Private Limited
Outcome results
None listed