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A Study Comparing Two Types of Blood Pressure Medicines in Patients with Stage 1 Hypertension

Comparative Study of Combination Therapy of Amlodipine 2.5 mg + Telmisartan 20 mg versus Amlodipine 5 mg Monotherapy in Stage 1 Hypertension. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092451
Enrollment
186
Registered
2025-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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: Amlodipine 2.5 mg + Telmisartan 20 mg: Amlodipine 2.5 mg + Telmisartan 20 mg Once Daily Control Intervention1: Amlodipine 5 mg: Amlodipine 5 mg once daily

Sponsors

Dr Kuldeep Desai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed consent from the participant as documented by signature. 2. Age 18 to 65 years. 3. Newly diagnosed, untreated hypertension according to JNC 8 guidelines: (a) Age 18 to 59 years: SBP more than equal to 140 mmHg or DBP more than equal to 90 mmHg (b) Age 60 to 65 years: SBP more than equal to 150 mmHg or DBP more than equal to 90 mmHg 4. History of smoking and alcohol consumption.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary hypertension. 2. Pregnant or lactating women. 3. Severe hepatic impairment. 4. Renal impairment. 5. Hypersensitivity to amlodipine, telmisartan, or any component of the formulations. 6. Participation in another interventional clinical trial within 4 weeks prior to baseline and during the current trial.

Design outcomes

Primary

MeasureTime frame
Possible Outcome-Amlodipine 2.5 mg + Telmisartan 20 mg more effective in reducing blood pressure compared to Amlodipine 5 mg.Timepoint: 3 Months

Secondary

MeasureTime frame
To compare the incidence and severity of adverse drug reactions, compare changes in Body Mass Index (BMI) and evaluate changes in lipid profile parameters between the two groups.Timepoint: 3 Months

Countries

India

Contacts

Public ContactDr Suraj Tripathi

Zydus Medical College and Hospital

surajpharmacol@gmail.com9926396896

Outcome results

None listed

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