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A study to compare the efficacy of two antihypertensive medication given in combination versus single antihypertensive medication after increasing its dose.

A comparative study to evaluate the efficacy and safety of increasing Telmisartan dose versus adding Amlodipine in patients with stage 1 hypertension - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073749
Enrollment
80
Registered
2024-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Telmisartan 80mg: Telmisartan 80mg once daily for 8 weeks Control Intervention1: Telmisartan 40mg + Amlodipine 5mg: Telmisartan 40mg + Amlodipine 5mg once daily for 8 weeks

Sponsors

Dr Spandana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to give informed consent and willing to follow up Patients having uncontrolled blood pressure more than 140mmHg systolic and more than 90mmHg diastolic blood pressure as per JNC guidelines who are on low dose monotherapy with Telmisartan for atleast 4 weeks

Exclusion criteria

Exclusion criteria: Patients having comorbidities like chronic kidney disease, stroke congestive heart failure coronary heart disease psychiatric disorders suspected secondary hypertension liver disease malignancy Pregnant and lactating mothers Patients with hypersensitivity to the study medications Psychiatric or emotional disturbance in patients which would limit ability of patients to comply The patient with increased levels of potassium The patient with hypertensive complications like retinopathy Cardiovascular disease nephropathy peripheral vascular disorder

Design outcomes

Primary

MeasureTime frame
Efficacy parameters Efficacy endpoints- reduction in systolic blood pressure by more than or equal to 15mmHg and diastolic blood pressure by more than or equal to 10mmHg from baseline Patients achieving target blood pressure of less than or equal to 140mmg systolic and 90mmHg diastolic blood pressureTimepoint: Baseline 4 weeks and 8 weeks

Secondary

MeasureTime frame
Safety parameters Safety is assessed by monitoring and recording adverse events reported by the patient at any time of the studyTimepoint: 4 weeks and 8 weeks

Countries

India

Contacts

Public ContactDr Spandana

Bangalore medical college and research centre

praveen.bmcri@gmail.com9632917662

Outcome results

None listed

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