NCT03527069已完成3 期
Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
EMS1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年1月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Reduction of serum triglyceride levels measured between the first visit and last visit.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Cipros 10 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 diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- •Signed consent.
排除标准
- •Diagnosis of familial hypercholesterolemia and other genetic diseases;
- •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 10
Experimental
The study is double-Masked, the patient wil take 2 tablets, as follow:
1 tablet Cipros 10 association; and
1 tablet crestor placebo Oral, once a day.
干预措施: Cipros 10 association (Drug)
Crestor
Active Comparator
The study is double-Masked, the patient wil take 2 tablets, as follow:
1 tablet Crestor 10mg; and
1 tablet Cipros association placebo Oral, once a day.
干预措施: Crestor 10 mg (Drug)
结局指标
主要结局
Reduction of serum triglyceride levels measured between the first visit and last visit.
时间窗: 12 weeks
次要结局
- Incidence and severity of adverse events recorded during the study.(13 weeks)
研究者
研究点 (1)
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