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
- Conditions
- Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart DiseaseMedDRA version: 8.1Level: LLTClassification code 10020604
- Registration Number
- EUCTR2005-005981-35-ES
- Lead Sponsor
- Kowa Research Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
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
All patients entering this study must have satisfied inclusion/exclusion criteria for the
previous core study (NK-104-304).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method