EUCTR2005-005981-35-GB进行中(未招募)1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •All patients entering this study must have satisfied inclusion/exclusion criteria for the
- •previous core study (NK-104-304). As participants in Study NK-104-304, patients have previously received pitavastatin (at 2 mg up-titrated to 4 mg QD after 4 weeks) or a comparator (simvastatin 20 mg up-titrated to 40 mg QD after 4 weeks) for a total of 12 weeks and followed a diet according to EAS guidelines (Appendix A) for 18 to 20 weeks. To be eligible for participation in this study the patients must have completed 12 weeks of active treatment in the core study (NK-104-304) and continue to follow the diet according to EAS guidelines.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All patients entering this study must have satisfied inclusion/exclusion criteria for the
- •previous core study (NK-104-304).
研究者
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