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

Phase 4

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

• Registration Number: CTRI/2024/03/064100
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients reporting incidences of adverse eventsTimepoint: Day 0 to Day 90

Secondary Outcome Measures

Name	Time	Method
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