Phase IV study comparing Efonidipine 40mg Tablet to Cilnidipine 10 Mg Tablet In The Management Of Hypertension

Phase 4

Completed

• Conditions: Essential (primary) hypertension, (2) ICD-10 Condition: I12||Hypertensive chronic kidney disease, (3) ICD-10 Condition: I15||Secondary hypertension,

• Registration Number: CTRI/2019/03/018167
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

**Study Title:** A multicentric, prospective, comparative, randomized phase IV study for evaluation of efficacy and safety of efonidipine 40 mg tablet in comparison to cilnidipine 10 mg tablet in the management of hypertension.

**Study Objective:** To evaluate the efiicacy and safety of efonidipine 40 mg in comparison with clinidipine 10 mg tablets.

**Primary Objective:** To assess and compare the efficacy of efonidipine 40 mg and cilnidipine 10 mg in blood pressure reduction.

**Secondary Objective:**

a) To evaluate and compare the effect of the two treatment groups on reduction of proteinuria.

b) To evaluate the number of patients achieving target BP as per JNC VIII guideline.

c) To evaluate and compare the safety of the two treatments over  a period of 3 months.

**Estimated Sample Size:** 1000 patients.A drop out rate of 20%shall be considered, therefore, total of 1200 patients may be recruited.

**Treatment:** Efonidipine and Cilnidipine groups will be randomised in 3:1 ratio.

**Study endpoints:**

**Primary outcomes:**

1. Mean change in sitting systolic blood pressure from day 0 to day 90.

2. Mean change in sitting diastolic blood  pressure from day 0 to day 90.

**Secondary outcomes:**

1. Changes in proteinuria from day 0 after day 90 of the treatment.

2. Mean change in systolic blood pressure from day 0 to day 30 and day 60.

3. Mean change in diastolic blood pressure from day o to day 30 and day 60.

4. Number of patients achieving target blood pressure as per JNC VIII guidelines for Hypertension.

5. Number of patients reporting incidences of adverse events or Serious adverse events

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Study Completion: 2023-01-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patients aged 18 to 65 years 2.
• Patients with Stage 1 hypertension (SBP/DBP: 140-159/90-99 mmHg) or stage II(SBP/DBP: ≥160/100 mmHg) hypertension as per Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII) 2.1. Subgroup of patients with stage I hypertension: Patients diagnosed with Stage I hypertension (JNC VII) 2.2. Subgroup of patients with renal impairment: Stage I or stage II hypertensive patients (JNC VII) diagnosed with renal impairment who do not need dialysis or replacement therapy 2.3. Subgroup of patients with Diabetes: Stage I or stage II hypertensive (JNC VII) patients with diabetes 3.
• Patients willing to sign informed consent.

Exclusion Criteria

• Patient with cerebrovascular disease in the previous 3 months.
• Patients with congestive heart failure, chronic arrhythmia, sick sinus syndrome or sinus bradycardia (< 50 beats/min) 3.
• Patients with second- or third-degree atrioventricular block 4.
• Patients with documented hypersensitivity to dihydropyridine calcium channel blockers or Efonidipine HCl 5.
• Women who are pregnant or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in sitting Systolic Blood Pressure (SBP)	From Baseline(Day 0) to Day 90
2. Mean change in sitting Diastolic Blood Pressure (DBP)	From Baseline(Day 0) to Day 90

Secondary Outcome Measures

Name	Time	Method
1. Changes in proteinuria	2. Mean Change in Systolic Blood Pressure (SBP) From Baseline (Day 0) to Day 30 and 60

Trial Locations

Locations (26)

Ambekar Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Bharatiya Arogya Nidhi Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Cardea clinic; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Vijay Alagappan Clinic; 🇮🇳 Chennai, TAMIL NADU, India

Dr. Vijay Mandoras Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Durgabai Deshmukh Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Excel Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Health Point Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Heart Rhythm Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Indopath Clinical Pvt. Ltd.; 🇮🇳 Kolkata, WEST BENGAL, India

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Ambekar Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Niranjan C Ambekar

Principal investigator

9822098670

dialysis97@gmail.com