A clinical trial to study the safety and efficacy of Efonidipine + Telmisartan in the treatment of hypertension.

A multicentric, open label study to evaluate the safety and efficacy of fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets in the management of Stage II hypertension. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064100

Enrollment

200

Registered

2024-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg Tablets: Fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets to be taken once daily for 90 days C

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults with age 18 years and above 2. Patients diagnosed with Stage II hypertension (SBP/DBP: 160/100 mmHg or above) 3. Naïve patients or patients able to switch from their current antihypertensive therapy without any risk to the patient on the investigator opinion 4. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to angiotensin II receptor blockers or dihydropyridine calcium channel blockers 2. Patients with history of severe, malignant or secondary hypertension 3. Patient with cerebrovascular disease in the previous 3 months 4. Patients with chronic arrhythmia, sick sinus syndrome or sinus bradycardia (less than 50 beats per min) 5. Patients with second or third degree atrioventricular block 6. Female patients who are pregnant, lactating

Design outcomes

Primary

Measure	Time frame
Number of patients reporting incidences of adverse eventsTimepoint: Day 0 to Day 90	—

Secondary

Measure	Time frame
Mean reduction in sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Timepoint: Day 30, 60 and 90;Number of patients achieving/maintaining the target BP as per JNC VIII guideline for Hypertension.Timepoint: Day 90	—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Limited

bhupesh.dewan@zuventus.com912235060000

Outcome results

None listed

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