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An observational study to understand usage and effect of Azilsartan in Indian patients with high blood pressure

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 - ZENITH

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/05/014303
Enrollment
1000
Registered
2018-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hypertension

Interventions

None listed

Sponsors

Torrent Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. To assess the mean change in clinic SBP and DBP levels from baseline to week 12Timepoint: At baseline At end of 12weeks

Secondary

MeasureTime frame
1.Percentage of Participants With Response. Response is defined as decrease of SBP â?¥20 mm Hg or decrease of DBP â?¥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. 3.To understand usage pattern of azilsartan as monotherapy or add-on with other antihypertensive drugs 4.To assess adverse events during study durationTimepoint: At baseline At end of 12 weeks

Countries

India

Contacts

Public ContactMr Altaf Makwana

Torrent Pharmaceuticals Ltd

pankajjha@torrentpharma.com7069000554

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026