A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and Effect of AZilsartan as MonothErapy or Add On TreatmeNt in Indian PaTients with Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- 1.To assess the mean change in clinic SBP and DBP levels from baseline to week 12
Study Overview
Brief Summary
This Non-Interventional, Multicenter, Prospective, Observational Study is to UNderstand the Effect of Azilsartan as monotherapy or add on treatment in Indian patients with hypertension (ZENITH Study). Total 1000 patients are planned from 20 different sites across India. The primary objective of the study is to assess the mean change in clinic SBP and DBP levels from baseline to week 12 in routine clinical practice treated with azilsartan either alone or add on therapy. Secondary objectives of study are (i) Percentage of participants with response [Time Frame: Baseline and week 12] (ii) Percentage of participants who achieve target BP <140 mm Hg (iii) To understand usage pattern of azilsartan as monotherapy or add-on with other antihypertensive drugs and (iv) to assess adverse events during study duration
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 85.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient willing to provide informed consent 2.Female or male patient aged 18 years or above 3.A treatment naive patient or a patient who are on treatment with other antihypertensive with grade 1 and 2 hypertension (SBP between 150 to 180) 4.Physician decides to prescribe azilsartan as a monotherapy or add-on 5.Patients must provide written consent to use personal and/or health data prior to the entry into the study.
Exclusion Criteria
- •1.Confirmed secondary hypertension 2.Patient taking a medicine acts upon RAAS e.g. ACEi or ARBs other than Azilsartan 3.Contraindications for azilsartan of respective approved local prescribing information.
- •4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent subject participation in the study 5.Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study.
Outcomes
Primary Outcomes
1.To assess the mean change in clinic SBP and DBP levels from baseline to week 12
Time Frame: At baseline | At end of 12weeks
Secondary Outcomes
- 1.Percentage of Participants With Response. Response is defined as decrease of SBP ≥20 mm Hg or decrease of DBP ≥10 mm Hg.(2. Percentage of Participants who Achieve Target BP 140 mm Hg.Target BP is defined as SBP 140 mm Hg and DBP 90 mm Hg.)