Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 20 Association on the Dyslipidemia Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Reduction of serum LDL-c
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of both sexes, aged 18 years or more;
- •Participants with the diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- •Signed consent.
排除标准
- •Using medications that may interfere with the metabolism or serum levels of triglycerides;
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Presence of concomitant cardiovascular disease, renal failure and hepatic failure;
- •Decompensated diabetes;
- •Current smoking;
- •History hypersensitivity to the active ingredients used in the study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •History of alcohol abuse or illicit drug use;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
Cipros 20
The study is double-masked, the patient will take 2 tablets, as follow:
1 tablet Cipros 20 association; and
1 tablet crestor placebo. Oral, once a day
干预措施: Cipros 20 association (Drug)
Crestor
The study is double-masked, the patient will take 2 tablets, as follow:
1 tablet Crestor 20 mg; and
1 tablet cipros association placebo. Oral, once a day
干预措施: Crestor 20 mg (Drug)
结局指标
主要结局
Reduction of serum LDL-c
时间窗: 12 weeks vs baseline
The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.
Reduction of serum triglyceride levels
时间窗: 12 weeks vs baseline
The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.
次要结局
- Incidence and severity of adverse events recorded during the study(13 weeks)