NCT00257686已完成3 期
Study Of Pitavastatin 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
Kowa Research Europe59 个研究点 分布在 5 个国家目标入组 962 人开始时间: 2005年9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
- 已完成
- 发起方
- 入组人数
- 962
- 试验地点
- 59
- 主要终点
- Percent Change From Baseline in LDL-C
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients
详细描述
Following a wash-out dietary lead-in period, patients will receive either Preavastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and postmenopausal females (aged 65 years and older
- •Eligible, able to participate, have given informed consent
- •Must have been following a restrictive diet
- •Diagnosis of primary hypercholesterolemia or combined dyslipidemia
- •Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
- •Agree to be available
- •Exclusion Criteria
- •Homozygous familial hypercholesterolemia
- •Conditions which may cause secondary dyslipidemia
- •Uncontrolled diabetes mellitus (HbA1c >8%).
- •Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
- •History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
- •Liver injury
- •Impaired renal function
- •Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
- •Serum CK >5 x ULRR without clinical explanation
- •Uncontrolled hypothyroidism defined as TSH >ULRR
- •Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
- •Major surgery, 3 months prior to Visit 1
- •Significant CVD prior to randomization
- •Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
- •Left ventricular ejection fraction <0.25;
- •History of symptomatic cerebrovascular disease
- •Any other conditions at the discretion of the investigator
- •Known HIV infection
- •Poorly controlled or uncontrolled hypertension
- •Prior or current known muscular or neuromuscular disease of any type;
- •Neoplastic disease
- •Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
- •Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
- •Current or recent use of supplements known to alter lipid metabolism
- •History of hypersensitivity to other HMG-CoA reductase inhibitors;
- •Concomitant medication not permitted
- •Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
- •Excessive obesity
- •Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
排除标准
- 未提供
研究组 & 干预措施
Pitavastatin 1 mg
Experimental
Pitavastatin 1 mg once daily
干预措施: Pitavastatin (Drug)
Pravastatin 10 mg
Active Comparator
Pravastatin 10 mg once daily
干预措施: Pravastatin (Drug)
Pitavastatin 2 mg
Experimental
Pitavastatin 2 mg once daily
干预措施: Pitavastatin (Drug)
Pravastatin 20 mg
Active Comparator
Pravastatin 20 mg once daily
干预措施: Pravastatin (Drug)
Pitavastatin 4 mg
Experimental
Pitavastatin 4 mg once daily
干预措施: Pitavastatin (Drug)
Pravastatin 40 mg
Active Comparator
Pravastatin 40 mg once daily
干预措施: Pravastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C
时间窗: Baseline to 12 weeks
Percent change from baseline in low density cholesterol (LDL-C)
次要结局
- Percent Change From Baseline in TC(Baseline to 12 weeks)
研究者
研究点 (59)
Loading locations...
相似试验
已完成
3 期
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined DyslipidemiaType II Diabetes MellitusDyslipidemiaNCT00309751Kowa Research Europe418
已完成
3 期
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol LevelsPrimary HypercholesterolemiaDyslipidemiaNCT00249249Kowa Research Europe830
已完成
3 期
Study to Compare the Efficacy and Safety of Pitavastatin and SimvastatinHypercholesterolemiaDyslipidemiaNCT00309738Kowa Research Europe355
已完成
3 期
Study to Compare the Efficacy and Safety of Pitavastatin and SimvastatinHypercholesterolemiaDyslipidemiaNCT00309777Kowa Research Europe857
进行中（未招募）
1 期
STUDY OF PITAVASTATIN 1 MG vs. PRAVASTATIN 10 MG, PITAVASTATIN 2 MG vs. PRAVASTATIN 20 MG AND PITAVASTATIN 4 MG vs. PRAVASTATIN 40 MG (FOLLOWING UP-TITRATION) IN ELDERLY PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIAPRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIAMedDRA version: 7.1 Level: LLT Classification code 10020604EUCTR2005-001039-31-GBKowa Research Europe Ltd.900