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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 26
- 主要终点
- 1. Mean change in sitting Systolic Blood Pressure (SBP)
研究概览
简要总结
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:
-
Mean change in sitting systolic blood pressure from day 0 to day 90.
-
Mean change in sitting diastolic blood pressure from day 0 to day 90.
Secondary outcomes:
-
Changes in proteinuria from day 0 after day 90 of the treatment.
-
Mean change in systolic blood pressure from day 0 to day 30 and day 60.
-
Mean change in diastolic blood pressure from day o to day 30 and day 60.
-
Number of patients achieving target blood pressure as per JNC VIII guidelines for Hypertension.
-
Number of patients reporting incidences of adverse events or Serious adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 years
- •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.
- •Subgroup of patients with stage I hypertension: Patients diagnosed with Stage I hypertension (JNC VII) 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.
- •Subgroup of patients with Diabetes: Stage I or stage II hypertensive (JNC VII) patients with diabetes
- •Patients willing to sign informed consent.
排除标准
- •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)
- •Patients with second- or third-degree atrioventricular block
- •Patients with documented hypersensitivity to dihydropyridine calcium channel blockers or Efonidipine HCl
- •Women who are pregnant or breast feeding.
结局指标
主要结局
1. Mean change in sitting Systolic Blood Pressure (SBP)
时间窗: From Baseline(Day 0) to Day 90
2. Mean change in sitting Diastolic Blood Pressure (DBP)
时间窗: From Baseline(Day 0) to Day 90
次要结局
- 1. Changes in proteinuria(2. Mean Change in Systolic Blood Pressure (SBP) From Baseline (Day 0) to Day 30 and 60)