CTRI/2021/03/031882尚未招募3 期
A Prospective Randomized Double-blind Double-dummy Parallel-group Investigator-initiated Study to Compare the Efficacy and Safety of Cilnidipine 10 mg Tablets versus Cilacar® Tablets 10 mg in Patients with Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in sitting SBP and DBP on Day 30 (±4 days) in both treatment groups
研究概览
简要总结
A Prospective, Randomized, Double-blind, Double-dummy, Parallel-group Investigator-initiated Study to Compare the Efficacy and Safety of Cilnidipine 10 mg Tablets versus Cilacar® Tablets 10 mg in Patients with Essential Hypertension,sample size 30,for 30 days Primary Efficacy Objective To evaluate the efficacy of investigational products in patients with essential hypertension on Day 30 (±4 days) of treatment as assessed by change from baseline in sitting SBP and DBP
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with essential hypertension with blood pressure more than or equal to 140/90 mmHg Patients who require monotherapy with Cilnidipine 10 mg tablets in the opinion of investigator Serum creatinine within the normal range defined by the local laboratory Patients willing to give their written informed consent to participate in the study Patients willing to comply with all aspects of the protocol.
排除标准
- •Blood pressure more than or equal to 180/110 mmHg,hypersensitive to active or inactive ingredients of investigational products,uncontrolled diabetes mellitus at screening,symptomatic hypotension,uncontrolled kidney disease requiring dialysis or renal ,replacement therapy,Apparent/pseudo hypertension due to white coat effect, and medical inertia,known history of heart failure, and reduce cardiac function,pedal edema, nephrotic syndrome, hypoproteinemia or microalbuminuria,Female patients who are pregnant, lactating, or planning to become pregnant,patients not willing to use acceptable method of contraception,hematologic, hepatic, biliary obstructive disorders, neurologic psychiatric, renal, cardiovascularendocrine, or other diseases or receiving any medication that, in the opinion of the investigator, would put the patient at riskthrough study period, or would affect the study analyses,scheduled to undergo surgery during the study period,who have received any intervention in a clinical trial within 01 month prior to screening,history of alcohol and/or drug/substance abuse and current significant alcohol Consumption.
结局指标
主要结局
Change from baseline in sitting SBP and DBP on Day 30 (±4 days) in both treatment groups
时间窗: 30 Days
次要结局
- Change from baseline in sitting SBP and DBP on Day 15 (±4 days) in both treatment groups Proportion of patients achieving goal BP during the study in both treatment groups at the end of treatment from baseline (Day 30 [± 4 days]) Change from baseline in body weight, pulse rate, pedal edema and ankle circumference (right and left) on Day 15(±4 days) and Day 30(±4 days) in both treatment groups. Change in spot urine-protein creatinine ratio on Day 30 (±4 days) from baseline(30 Days)
研究者
研究点 (1)
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