A Multi-Center, Double-Blind, Randomized, Superiority Clinical Study to Compare the Effects of Cilnidipine on Metabolic Syndrome Improvement With Nifedipine GITS in Hypertensive Patients With Metabolic Syndrome (Phase IV) [SLIMS]
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Homeostasis model assessment of insulin sensitivity (HOMA-IR)
研究概览
简要总结
Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with hypertension, and these metabolic abnormalities are reported to be related to insulin resistance. Therefore, whenever treating such patients, antihypertensive agents that may have the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine) is expected to improve metabolic syndrome as well as insulin resistance by its dual effects on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects of CinalongTM on insulin resistance and other metabolic related factors.
详细描述
- Multi-center, randomized, prospective, double blind, active control, parallel study
- Superiority study (Treatment group - Cilnidipine/Control group - Nifedipine)
- Measure the effects of Cinalong(TM) after 3 month and 12 month-application
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, 30-65 years of age having essential hypertension with metabolic syndrome
- •At Screening and Visit 1, blood pressure should be: sitting systolic blood pressure (SiSBP) >=140 mmHg or sitting diastolic blood pressure (SiDBP)>= 90 mmHg and two or more of the following criteria should apply.
- •Abdominal obesity: waist circumference >= 90 cm in men and >= 80 cm in women
- •Hypertriglyceridemia:. >=150 mg/dl (1.695 mmol/l)
- •Low HDL cholesterol: < 40 mg/dl (1.036 mmol/l) in men and < 50 mg/dl (1.295 mmol/l) in women
- •High fasting glucose: >= 110 mg/dl (6.1 mmol/l)
排除标准
- •Secondary hypertension
- •Malignant hypertension
研究组 & 干预措施
Nifedipine
parrallel design
干预措施: Cilnidipine (Drug)
Cilnidipine
干预措施: Cilnidipine (Drug)
结局指标
主要结局
Homeostasis model assessment of insulin sensitivity (HOMA-IR)
时间窗: after 3 month and 12 month treatment
Triglyceride/HDL cholesterol ratio
时间窗: after 3 month and 12 month treatment
次要结局
- Quantitative insulin-sensitivity check index (QUICKI)(after 3 month and 12 month treatment)
- Resting norepinephrine(after 3 month and 12 month treatment)
- Change in blood glucose(after 3 month and 12 month treatment)
- Change in cholesterol(after 3 month and 12 month treatment)
- Decrease in trough SiSBP&SiDBP(after 3 month and 12 month treatment)
- Change in triglyceride(after 3 month and 12 month treatment)
- Resting heart rate(after 3 month and 12 month treatment)
- Change in abdominal obesity(after 3 month and 12 month treatment)