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

A Multicentric, Prospective, Comparative, Randomized Phase-IV Study For Evaluation Of Efficacy And Safety Of Efonidipine 40mg Tablet In Comparison to Cilnidipine 10 Mg Tablet In The Management Of Hypertension

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/03/018167

Enrollment

1200

Registered

2019-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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 Health Condition 2: I12- Hypertensive chronic kidney disease Health Condition 3: I15- Secondary hypertension

Interventions

Intervention1: Efonidipine 40mg tablet: One tablet of 40 mg to be taken orally once a day for 90 days Control Intervention1: Cilnidipine 10 mg tablet: One tablet of 10 mg to be taken orally once a day

Eligibility

Inclusion criteria

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

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 ( 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

Design outcomes

Primary

Measure	Time frame
1. Mean change in sitting Systolic Blood Pressure (SBP) 2. Mean change in sitting Diastolic Blood Pressure (DBP)Timepoint: From Baseline(Day 0) to Day 90	—

Secondary

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

Measure

Time frame

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