Health Condition 1: null- Adults patients of Essential hypertension with or without associated Cardiovascular Complications
Conditions
Interventions
Intervention1: Tablet Azilsartan medoxomil 20 mg: 20 mg tablet to be taken once daily for 14 days
Intervention2: Tablet Azilsartan Medoxomil 40 mg: 20 mg tablet to be taken once daily for the first 14
Sponsors
MSN Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients of age between 18-65 years. 2.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form. 3.Patients newly diagnosed (first-time diagnosis during screening or within three months before the first day of screening) with Essential Hypertension of Stage 1 with SBP ranging between 140 159 mmHg and / or DBP ranging between 90-99 mmHg. 4.Patients currently: a) on anti-hypertensive drug therapy (for phase A as well as phase B) or b) without anti-hypertensive drug therapy (for phase B only) 5.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 6.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements. 7.Patients willing to discontinue current anti-hypertensive drug therapy (if applicable).
Exclusion criteria
Exclusion criteria: 1.Patients (essentially â??newly diagnosedâ??) who will be at a significant medical risk arising out of deprivation of regular anti-hypertensive drug treatment during the washout period. 2.Patients with a history of chronic kidney disease, renal artery stenosis, excessive aldosterone secretion, pheochromocytoma, or sleep apnea. 3.Patients with severe renal impairment (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 history of hyperkalemia. 6.Patient with known history of unstable cardiovascular disease and/or signiï¬?cant cardiac conduction defects. 7.Patient with Type 1 or Type 2 Diabetes Mellitus. 8.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 |
|---|---|
| Efficacy: Mean reduction in the trough sitting clinic SBP and DBP from baseline to Day 14 (±2) and Day 43(+1) Safety: Percentage of patients reporting AE and/or SAE during the study, its frequency, severity, pattern and causal relationship to the drug.Timepoint: Efficacy: Baseline to each post randomization visit [Day1, 14, 42 and 43] Safety: Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43] Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 24 hour mean (average of all measurements for 24 hours) SBP and DBP.Timepoint: On day 43 (or 44) as compared to baseline | — |
Countries
India
Contacts
Public ContactMangesh Khadakban
Nexus Clinical Research (India) Ltd.
Outcome results
None listed