Health Condition 1: null- Patients with Hypertension
Conditions
Interventions
Intervention1: Azilsartan Medoxomil: All participants will receive azilsartan 80 mg once daily for 12 weeks
Control Intervention1: NA: NA
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed hypertensive patients. 2.Seated BP of more than 140 mm Hg SBP and 90 mm Hg DBP in subjects who are already on dual drug therapy for at least 1 month. 3.Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion) 4. Subjects willing to complete all study-related procedures
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast feeding women 2. Subjects with serious medical condition 3. Patients with contraindications or hypersensitivity to any component of the formulation 4. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication Subjects participating in another investigational drug trial within 4 weeks of trial enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in mean seated SBP and DBP at the end of 12 weeks from the baseline.Timepoint: Baseline, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Global assessment of efficacy and tolerability as evaluated by physician using a 4-point scaleTimepoint: Baseline to end of the study (12 weeks);â?¢ Safety assessment of Azilsartan based on the adverse effects as mentioned by the patient and as evaluated by the treating physicianTimepoint: Baseline to end of the study (12 weeks) | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar M
Micro Labs Limited, Bangalore
Outcome results
None listed