A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones

Organon and Co0 个研究点目标入组 214 人开始时间: 2001年12月最近更新: 2024年8月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Organon and Co
入组人数: 214
主要终点: Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).

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: 30 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
•Additionally, patients must have an LDL-C >100 mg/dL at Visit 1 or prior to initiation of statin therapy

排除标准

•Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
•Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

结局指标

主要结局

Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements

时间窗: 6 & 12 Weeks

次要结局

Well tolerated in patients in Diabetic patients(30 Weeks)

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

4 期

Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)AtherosclerosisHypercholesterolemiaCoronary Heart Disease

NCT00651274Organon and Co144

已完成

3 期

Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)AtherosclerosisHypercholesterolemiaCoronary Artery Disease

NCT00650689Organon and Co122

已完成

4 期

Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)AtherosclerosisHypercholesterolemia

NCT00650663Organon and Co247

已完成

3 期

Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)Primary Hypercholesterolemia

NCT00867165Organon and Co138

已完成

3 期

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin TherapyHyperlipidemias

NCT03337308Esperion Therapeutics, Inc.382