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A Clinical Study to evaluate the effect of two different combinations of BP medication in patients with uncontrolled BP

A clinical assessment to evaluate the effect of two different combinations of anti-hypertensive drugs (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10 mg among Subjects with uncontrolled hypertension in India â?? A prospective, randomized, investigator initiated study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015555
Enrollment
200
Registered
2018-08-31
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: I10- Essential (primary) hypertension

Interventions

Intervention1: Combinations of antihypertensive drugs (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10) mg: This study will have simple random sampling procedure (Alte

Sponsors

Current Medical Concepts Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Adults greater than or equal to 18 years and less than or equal to 70 years old both male and female. b) Subjects with uncontrolled BP who are on monotherapy. c) Systolic Blood Pressure (SBP) >130 mmHg and Diastolic Blood Pressure (DBP) > 80 mmHg based on three consecutive blood pressure readings d) Any stage of Hypertension. e) Willing to give written informed consent

Exclusion criteria

Exclusion criteria: a) Women of child bearing potential b) History of Myocardial infarction, Acute stroke, Acute kidney injury in the last 3 months c) Subjects with history of congestive heart failure. d) Subjects with advanced CKD with Serum Creatinine value > 2.5 mg/dL. e) History of allergy to calcium channel blockers and angiotensin receptor blockers f) Inability to give informed consent g) Subject with hypertensive crisis (Seated BP greater than or equal to 180/120 mmHg) on the day of screening. h) Subjects unwilling/unable to adhere to the study protocol.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of two different treatments on BP levels in Subjects with HypertensionTimepoint: Screening and Week 8 (end of study)—

Secondary

MeasureTime frame
To assess the safety and tolerability of combination therapy from baseline to end of studyTimepoint: Between Baseline to end of study—

Countries

India

Contacts

Public ContactG Praveen Kumar

Apollo Hospitals

drram_v@apollohospitals.com7799806040

Outcome results

None listed

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