NCT00254475已完成3 期
A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 871
- 试验地点
- 2
- 主要终点
- Low density lipoproteins after 6 weeks
研究概览
简要总结
The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •Elevated LDL-Cholesterol
- •Essential hypertension
排除标准
- •Severe Hypertension
- •Prior or known muscular or neuromuscular disease of any type
- •A history of cardiovascular disease
- •Hypertension or hypercholesterolemia due to secondary causes
- •Uncontrolled diabetes or insulin treatment
- •Evidence of hepatic or renal disease
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Low density lipoproteins after 6 weeks
次要结局
- Lipid profile at 6, 12 wks
- BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks
- SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks
- Systolic and diastolic bp at 6, 12 wks
- Serious/adverse events, labs, physical exams, vitals up to 12 wks
研究者
研究点 (2)
Loading locations...
相似试验
终止
4 期
The Effect of Lipitor on Aortic StenosisAortic Valve StenosisNCT00590135The Cleveland Clinic59
已完成
1 期
Drug Interaction Study of Simvastatin and DabigatranHealthyNCT03728101Korea University Guro Hospital12
已完成
3 期
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)Lupus Erythematosus, SystemicNCT00065806Laura Schanberg221
已完成
1 期
Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell DiseaseSickle Cell DiseaseNCT01702246UCSF Benioff Children's Hospital Oakland24
已完成
4 期
Systems Biological Assessment of Statin Effect on Vaccine ResponsesVaccine ResponseNCT06024096Emory University63