A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
研究概览
简要总结
The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.
排除标准
- •Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
- •Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
- •Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)
研究组 & 干预措施
Caduet 10/20mg
Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.
干预措施: Amlodipine besylate/atorvastatin calcium single pill combination (Drug)
Norvasc 5 mg
Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.
干预措施: Amlodipine besylate (Drug)
Norvasc 10 mg
Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.
干预措施: Amlodipine besylate (Drug)
Caduet 5/20mg
Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .
干预措施: Amlodipine besylate/atorvastatin calcium single pill combination (Drug)
结局指标
主要结局
Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
时间窗: Week 6
Number of subjects reaching dual goal of systolic blood pressure \<140 millimeters of mercury (mmHg) and diastolic blood pressue of \<90 mmHg and low density lipoprotein-cholesterol(LDL-C) \<100 milligrams per deciliter(mg/dL)
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
时间窗: Week 6, baseline
Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction \[MI\] or CHD death) are calculations based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.
次要结局
- Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4(Week 4)
- Subjects With LDL-C < 100 mg/dL at Week 4(Week 4)
- Change From Baseline in Triglycerides (TG) at Week 6.(Week 6 , baseline)
- Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.(Week 4, baseline)
- Change From Baseline to Week 4 in Pulse Rate(Week 4, baseline)
- Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)(Week 6, baseline)
- Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)(Week 6, baseline)
- Change From Baseline in LDL at Week 4.(Week 4, baseline)
- Subjects With BP < 140/90 mmHg at Week 4(Week 4)
- Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.(Week 4)
- Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.(Week 6)
- Subjects With LDL-C < 100 mg/dL at Week 6(Week 6)
- Subjects With BP < 140/90 mmHg at Week 6(Week 6)
- Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)(Week 4, baseline)
- Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).(Week 4, baseline)
- Change From Baseline to Week 6 in Pulse Rate(Week 6, baseline)
- Change From Baseline in High Density Lipoprotein (HDL) at Week 4.(Week 4, baseline)
- Change in Total Cholesterol (TC) From Baseline to Week 4.(Week 4, baseline)
- Change From Baseline in Triglycerides (TG) to Week 4.(Week 4, baseline)
- Change From Baseline in LDL at Week 6.(Week 6, baseline)
- Change From Baseline in HDL at Week 6.(Week 6, baseline)
- Change From Baseline in Total Cholesterol (TC) to Week 6.(Week 6, baseline)