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Comparative study of telmisartan and amlodipine combination vs telmisartan in Indian patients with high blood pressure

To assess the safety and effectiveness of telmisartan/amlodipine in comparison to telmisartan in Indian patients with hypertension through a real-world, retrospective, Observational study (CONTROL Study) - CONTROL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/095719
Enrollment
14000
Registered
2025-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: I10-I16- Hypertensive diseases

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult Male or female patients with newly diagnosed hypertension (BP more than 140/90 mmHg) 2. Patients diagnosed with hypertension and treated with telmisartan & amlodipine combination or telmisartan monotherapy as initial line therapy

Exclusion criteria

Exclusion criteria: 1. Patients with current or past exposure to antihypertensive medications other than study drug

Design outcomes

Primary

MeasureTime frame
1. Mean change in seated SBP & DBPTimepoint: from baseline at 12 2 weeks

Secondary

MeasureTime frame
1. Proportion of patients achieving BP control (defined as mean seated SBP less than 130 mmHg and DBP less than 80 mmHg).Timepoint: at 12 2 weeks;2. Proportion of patients who sustained or improved on BP control achievedTimepoint: at 12 2 weeks over 24 2 weeks;3. Incidence of adverse eventsTimepoint: at any subsequent visit post baseline

Countries

India

Contacts

Public ContactDr Mukesh Gabhane

Torrent Pharmaceuticals Ltd.

mukeshgabhane@torrentpharma.com7069000639

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026