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A study to understand the Effect of anti-hypertensive medication on the control of Blood Pressure in patients with Hypertension and Heart Disease.

Effectiveness and Tolerability of Metosartan CH (Metoprolol Succinate Extended Release, Telmisartan and Chlorthalidone Fixed Dose Combination) on Blood Pressure Control in Patients of Essential Hypertension with Stable Coronary Artery Disease in India: A Real-World Retrospective Study from ElectroNic Medical RecOrds (MECHANO Study) - MECHANO

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/060349
Enrollment
1793
Registered
2023-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Sun Pharma Laboratories Limited (SPLL)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged =18 years of either gender Patients with essential hypertension (SBP =140 mmHg and/or DBP =90 mmHg) and stable coronary artery disease (CAD), as diagnosed by their treating physician Patients prescribed with Metosartan CH by their treating physicians Patients with available data on blood pressure (systolic and diastolic) assessment conducted as a part of routine clinical practice at least at baseline, post-baseline follow-up visits, and up to 24±2 weeks of treatment with Metosartan CH Patients with availability of essential data such as age, gender, BMI/weight, comorbidities if any, prior history of hypertension, duration of hypertension, history of smoking/alcohol consumption (if available), concomitant medication, and laboratory data (if any relevant tests are done and report is available)

Exclusion criteria

Exclusion criteria: Patients with incomplete records with respect to the required study parameters Patients with a history of allergy or contraindications to study medication

Design outcomes

Primary

MeasureTime frame
Mean change in systolic BP (SBP) and diastolic BP (DBP) from baseline to post-index (composite of Metosartan CH discontinuation, addition of new therapy, or completion of 24±2 weeks of treatment with Metosartan CH)Timepoint: Baseline to 24+/-2 Weeks

Secondary

MeasureTime frame
Mean change in systolic BP (SBP) and diastolic BP (DBP) from baseline to 24±2 Weeks of treatment with Metosartan CH Proportion of patients achieving target BP (SBP Proportion of patients achieving target SBP of Proportion of patients achieving target DBP of Mean change in systolic BP (SBP) and diastolic BP (DBP) from baseline to 24±2 weeks of treatment with Metosartan CH, upon stratification of patients by age, gender, weight/BMI, and comorbidities Proportion of patients with adverse eventsTimepoint: Baseline to 24±2 Weeks;Mean change in systolic BP (SBP) and diastolic BP (DBP) from baseline to next available follow-up visits before 24 weeks Proportion of patients achieving BP goals (SBP Proportion of patients achieving target SBP of Proportion of patients achieving target DBP of Mean change in systolic BP (SBP) and diastolic BP (DBP) from baseline to next available follow-up visits before 24 weeks, upon stratification of patients by age, gender, weight/BMI, and comorbiditiesTimepoint: Before 24 weeks

Countries

India

Contacts

Public ContactMs Colette Pinto

Sun Pharma Laboratories Limited

Neeraj.Markandeywar@sunpharma.com02243244324

Outcome results

None listed

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