Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
None listed
Sponsors
Dr Ramesh Dargad
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients of age 18 years to 65 years (both inclusive) 2.Treatment-naïve hypertensive patients or those who are uncontrolled with their current antihypertensive therapy and are prescribed Azilsartan as add-on therapy 3.Patients with essential hypertension with SBP ranging between 140 – 159 mmHg and/or DBP ranging between 90 – 99 mmHg. 4.Female patients of childbearing potential who are sexually active must agree to use adequate contraception, and should neither be pregnant nor lactating from screening throughout the duration of the study 5.Patients willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements. 6.Patients willing to discontinue current anti-hypertensive drug therapy (if applicable). 7.Patients or patient’s legally acceptable representative willing to sign the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.Patients with secondary hypertension 2.Patients with a history of chronic kidney disease (CKD), renal artery stenosis, excessive aldosterone secretion, pheochromocytoma, or sleep apnea 3.Patients with severe renal impairment (known eGFR 4.Patients with severe hepatic impairment [SGOT, SGPT and S. Bilirubin (total) =1.5 times the upper limit of normal reference values] 5.Patients with known history of episodes of hyperkalemia 6.Patient with known history of unstable cardiovascular disease and/or signi ?cant cardiac conduction defects 7.Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months 8.Patients with known history of gout 9.Patients suffering from pre-existing severe cough 10.Patients with history of cardiac surgery in past 3 months prior to screening 11.Known or suspected hypersensitivity to any drug that will be administered during the study 12.Inability to comply with the protocol requirements 13.Participation in any other clinical trial within 3 months of registering in this trial 14.Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change from baseline in the mean 24-hr SBP and DBP on ABPM at the end of study visit (6-12 weeks) 2.Change from baseline in mean morning SBP and DBP 3.Change from baseline in daytime mean for SBP and DBP 4.Change from baseline in night-time mean for SBP and DBP Timepoint: 6-12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Clinical adverse events over the study period (6-12 weeks) Timepoint: (6-12)weeks;2. Change in laboratory parameters (lipid profile, serum uric acid, serum electrolytes, serum creatinine and HbA1C) from baseline over 6-12 weeks of study period Timepoint: (6-12)weeks | — |
Countries
India
Contacts
Public ContactDr Ramesh Dargad
Stress Test Clinic
Outcome results
None listed