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

Phase 4

Completed

Conditions: Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: I12- Hypertensive chronic kidney diseaseHealth Condition 3: I15- Secondary hypertension

Registration Number: CTRI/2019/03/018167

Lead Sponsor: Zuventus Healthcare Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1200

Inclusion Criteria

1. 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

1. Patient with cerebrovascular disease in the previous 3 months.

2. 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) <br/ ><br>2. Mean change in sitting Diastolic Blood Pressure (DBP)Timepoint: From Baseline(Day 0) to Day 90

Secondary Outcome Measures

Name	Time	Method
1. Changes in proteinuria <br/ ><br>2. Mean Change in Systolic Blood Pressure (SBP) From Baseline (Day 0) to Day 30 and 60 <br/ ><br>3. Mean Change in Diastolic Blood Pressure (DBP) <br/ ><br>4. Number of subjects achieving target BP as per JNC VIII guidelines for Hypertension. <br/ ><br>5. Number of subjects reporting incidences of adverse events or Serious Adverse eventsTimepoint: 1. From baseline (Day 0) after Day 90 <br/ ><br>2. From Baseline (Day 0) to Day 30 and 60 <br/ ><br>3. From Baseline (Day 0) to Day 30 and 60 <br/ ><br>4. On day 90 <br/ ><br>5. Throughout study duration