DOUBLE-BLIND FOLLOW-ON STUDY OF PITAVASTATIN (4 MG) VERSUS ATORVASTATIN (20 MG AND 40 MG), WITH A SINGLE-BLIND EXTENSION OF TREATMENT, IN PATIENTS WITH TYPE II DIABETES MELLITUS AND COMBINED DYSLIPIDEMIA

• Conditions: Patients with type II diabetes mellitus and combined dyslipidemia; MedDRA version: 8.1Level: LLTClassification code 10058110Term: Dyslipidemia

• Registration Number: EUCTR2005-006041-16-DK
• Lead Sponsor: Kowa Research Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

All patients entering this study must have satisfied inclusion/exclusion criteria for the previous core study (NK-104-305, EudraCT number 2005-001038-34). As participants in Study NK 104 305, patients have previously received pitavastatin (at 2 mg up-titrated to 4 mg QD after 4 weeks) or a comparator (atorvastatin 10 mg up-titrated to 20 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-104-305) 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

Exclusion Criteria

All patients entering this study must have satisfied inclusion/exclusion criteria for the previous core study (NK-104-305).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified