NCT02662894撤回3 期
Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
EMS0 个研究点开始时间: 2019年10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
- Percentage of participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .
研究概览
简要总结
Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.
详细描述
- Open-label,randomized, multicenter;
- Maximal experiment duration: 8 weeks;
- 04 visits;
- Safety and efficacy evaluation
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of both sexes aged between 18 and 65 years;
- •Participants diagnosed with uncontrolled hypertension;
- •Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- •Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) .
排除标准
- •Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
- •Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);
- •participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- •research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL;
- •participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;
- •research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position);
- •History of congestive heart failure (CHF) functional class III or IV (NYHA);;
- •any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Creatine phosphokinase (CPK) levels above the established laboratory normal range;
- •Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range;
- •Body mass index (BMI) ≥35 kg / m²;
- •Immunocompromised participants (eg .: malignancies, patients with Acquired Immunodeficiency Syndrome etc);
- •Chronic use of drugs that may interact with the drugs of the study;
- •Patients on concomitant lipid-lowering therapy;
- •History hypersensitivity to the active ingredients used in the study;
- •Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;
- •History of alcohol abuse or illicit drug use;
- •Adherence to uniformization medication <80%;
- •Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;
研究组 & 干预措施
Valsartan 160mg + Rosuvastatin 20mg
Experimental
Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.
干预措施: Valsartan 160mg + Rosuvastatin 20mg (Drug)
Valsartan 320mg + Rosuvastatin 20mg
Experimental
Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.
干预措施: Valsartan 320mg + Rosuvastatin 20mg (Drug)
Diovan® 160mg + Crestor® 20mg
Active Comparator
Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
干预措施: Diovan® 160mg + Crestor® 20mg (Drug)
Diovan® 320mg + Crestor® 20mg
Active Comparator
Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
干预措施: Diovan® 320mg + Crestor® 20mg (Drug)
结局指标
主要结局
Percentage of participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .
时间窗: 8 weeks
Reduction of systemic blood pressure measured between the first visit and last visit.
时间窗: 8 weeks
次要结局
- Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.(8 weeks)
研究者
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