Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
- Conditions
- Type II Diabetes MellitusDyslipidemia
- Interventions
- Registration Number
- NCT00344370
- Lead Sponsor
- Kowa Research Europe
- Brief Summary
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- Type II diabetes mellitus
- Combined dyslipidemia
- Completed NK-104-305 (NCT00309751)
- Withdrawal from NK-104-305 (NCT00309751)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitavastatin Pitavastatin Pitavastatin 4 mg QD Atorvastatin Atorvastatin Atorvastatin 40 mg
- Primary Outcome Measures
Name Time Method NCEP LDL-C Target Attainment 44 weeks Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in LDL-C Basseline to 44 weeks Percent change from baseline in LDL-C at 44 weeks
Trial Locations
- Locations (35)
CCBR Aalborg
🇩🇰Aalborg, Denmark
CCBR A/S
🇩🇰Vejle, Denmark
CCBR Vejle
🇩🇰Vejle, Denmark
Gemeinschaftspraxis am Bahnhof
🇩🇪Berlin-Spandau, Germany
Pharmakologisches Studienzentum Chemnitz
🇩🇪Chemnitz, Germany
Internistische Diabetische Schwerpunktpraxis Dr.
🇩🇪Frankfurt Am Main, Germany
Internistische Gemeinschaftspraxis
🇩🇪Mainz, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
🇩🇪Messkirch, Germany
Bhagwan Mahaveer Jain Heart Centre
🇮🇳Bangalore, India
Sri Ramachandra Medical College Hospital
🇮🇳Chennai, India
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