NCT04970108撤回3 期
National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension
EMS0 个研究点开始时间: 2023年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Systolic blood pressure (SBP)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Egito association in the treatment of type 2 diabetes mellitus and hypertension
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
- •Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
- •Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •History of alcohol abuse or illicit drug use;
- •Participation in a clinical trial in the year prior to this study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Known hypersensitivity to any of the formula compounds;
- •Type 1 diabetes mellitus;
- •Known or suspected secondary hypertension.
研究组 & 干预措施
Egito
Experimental
The study is triple-dummy. The patient must take 3 tablets once a day, as follows:
1 tablet Egito, oral;
1 tablet empagliflozin placebo, oral;
1 tablet telmisartan placebo, oral.
干预措施: Egito (Drug)
Empagliflozin + telmisartan
Active Comparator
The patient must take 3 tablets once a day, as follows:
1 tablet Egito placebo, oral;
1 tablet empagliflozin, oral;
1 tablet telmisartan, oral.
干预措施: Empagliflozin + telmisartan (Drug)
结局指标
主要结局
Systolic blood pressure (SBP)
时间窗: 120 days
Changes from baseline in SBP in ambulatory blood pressure monitoring
Glycated hemoglobin
时间窗: 120 days
Changes from baseline in glycated hemoglobin
次要结局
- Adverse events(150 days)
研究者
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