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.

Phase 3

Completed

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2020/12/029740
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

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

1. Patients with known hypersensitivity to β-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 ( < 50 beats/min).

5. Patients with second- or third-degree atrioventricular block.

6. Women who are pregnant, lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified