临床试验/NCT01256476

NCT01256476已完成4 期

A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA

Kowa Research Institute, Inc.0 个研究点目标入组 328 人开始时间: 2010年10月最近更新: 2012年5月8日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Kowa Research Institute, Inc.
入组人数: 328
主要终点: Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12

研究概览研究设计入排标准研究组 & 干预措施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

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed 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: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
•Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

排除标准

•Homozygous familial hypercholesterolemia
•Any conditions which may cause secondary dyslipidemia
•Uncontrolled diabetes mellitus

研究组 & 干预措施

pitavastatin 4 mg once daily (QD)

Experimental

干预措施: pitavastatin (Drug)

pravastatin 40 mg once daily (QD)

Active Comparator

干预措施: pravastatin (Drug)

结局指标

主要结局

Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12

时间窗: Baseline and 12 weeks

次要结局

未报告次要终点

研究者

发起方

Kowa Research Institute, Inc.

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

3 期

Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined DyslipidemiaType II Diabetes MellitusDyslipidemia

NCT00344370Kowa Research Europe214

已完成

3 期

Double-blind follow-on study of Pitavastatin (4 mg) versus Simvastatin (40 mg and 80 mg), with a single-blind extension of treatment, in patients with Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or more risk factors for Coronary Heart Disease

NL-OMON30052Kowa Research Europe50

进行中（未招募）

1 期

Double-blind follow on study of pitavastatin (4 mg)versus atorvastatin (20 and 40 mg), with a single-blind extension of treatment, in patients with type II diabetes mellitus and combined dyslipidemia

EUCTR2005-006041-16-GBKowa Research Europe Ltd.250

已完成

3 期

Double-Blind follow-on study of Pitavastatine (4mg)versus atorvastatine (20 mg and 40 mg), with a single extension of treatment in patients with type II Diabetes Mellitus and Combined Dyslipidemia

NL-OMON30046Kowa Research Europe50

Unknown

4 期

China Protection Trial of Glucose Metabolism by Pitavastatin in Patients With Prediabetes and HypertensionPrediabetic StateDyslipidemiasHypertension

NCT03532620Jun Tao396