A Phase III clinical study to compare efficacy and safety of Efonidipine and S(-)Metoprolol combination when compared to Cilnidipine and Metoprolol combination in patients with high blood pressure.

A multicentric, randomized, double blind, parallel, comparative study to demonstrate the non-inferiority of fixed dose combination of Efonidipine 40 mg and S (-) Metoprolol 25 mg tablet to fixed dose combination of Cilnidipine 10 mg and Metoprolol 50 mg tablet in the management of hypertension.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029740

Enrollment

240

Registered

2020-12-11

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: Fixed-dose combination of Efonidipine 40 mg and S (-) Metoprolol 25 mg tablets.: One tablet to be taken orally once daily for 90 days Control Intervention1: Fixed-dose combination of Ci

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Stage-I hypertension (SBP/DBP: 140-159 / 90-99 mmHg) or Stage-II hypertension (SBP/DBP: >= 160 / 100 mmHg). 2. Patients able to switch all prior antihypertensive medications safely to study medication (Investigatorâ??s discretion). 3. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to Î²-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 ( 5. Patients with second- or third-degree atrioventricular block. 6. Women who are pregnant, lactating.

Design outcomes

Primary

Measure	Time frame
1. Mean reduction in sitting Systolic Blood Pressure. 2. Mean reduction in sitting Diastolic Blood Pressure.Timepoint: 1. Day 0 , Day 90. 2. Day 0 , Day 90.	—

Secondary

Measure	Time frame
1. Number of patients achieving target BP as per JNC VIII guideline for Hypertension. 2. Mean reduction in sitting Systolic Blood Pressure. 3. Mean reduction in sitting Diastolic Blood Pressure. 4. Number of patients reporting incidences of adverse events.Timepoint: 1. Day 90. 2. Day 0 , Day 30, Day 60. 3. Day 0 , Day 30, Day 60. 4. Throughout study duration.	—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Limited

Bhupesh.Dewan@zuventus.com022-30610000

Outcome results

None listed

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