Dyslipidemia Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 214 |
| Est. completion date | April 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Type II diabetes mellitus - Combined dyslipidemia - Completed NK-104-305 (NCT00309751) Exclusion Criteria: - Withdrawal from NK-104-305 (NCT00309751) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | CCBR Aalborg | Aalborg | |
| Denmark | CCBR A/S | Vejle | |
| Denmark | CCBR Vejle | Vejle | |
| Germany | 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 | |
| India | Bhagwan Mahaveer Jain Heart Centre | Bangalore | |
| India | Sri Ramachandra Medical College Hospital | Chennai | |
| India | Apollo Hospitals | Hyderabaad | |
| India | CARE Group of Hospitals | Hyderabaad | |
| India | PD Hinduja Hospital | Mumbai | |
| Netherlands | Andromed Breda | Breda | |
| Netherlands | Andromed Eindhoven | Eindhoven | |
| Netherlands | Andromed Noord | Groningen | |
| Netherlands | Andromed Leiden | Leiden | |
| Netherlands | Andromed Nijmegen | Nijmegen | |
| Netherlands | Andromed Rotterdam | Rotterdam | |
| Netherlands | Andromed Oost | Velp | |
| Netherlands | Andromed Zoetermeer | Zoetermeer | |
| Poland | Podlaski Osrodek Kardiologii | Bialystok | |
| Poland | NZOZ GCP Dobra Praktyka Lekaska | Gruziadz | |
| Poland | NZOZ Terapia Optima | Katowice | |
| Poland | NZOZ Esculap, Przychodnia Lekary Rodzinnych | Losice | |
| Poland | NZOZ Centrum, Poradnia Kardiologiczna | Siedlce | |
| Poland | Spec. Gab. Lek. Internistyczno-Kardiologicznly | Tarnow | |
| Poland | Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego | Tychy | |
| Poland | Instytut Zywnosci i Zywienia | Warszawa | |
| Poland | Lecznica PROSEN SMO | Warszawa | |
| Poland | Szpital Wolski,im. Dr A. Gostynskiej | Warszawa | |
| United Kingdom | Synexus Reading Clinical Research Centre | Berkshire | |
| United Kingdom | Synexus Lancashire Clinical Research Centre | Lancashire | |
| United Kingdom | Synexus Merseyside Clinical Research Centre | Liverpool | |
| United Kingdom | Synexus Manchester Clinical Research Centre | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Kowa Research Europe |
Denmark, Germany, India, Netherlands, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NCEP LDL-C Target Attainment | 44 weeks | No | |
| Secondary | Percent Change From Baseline in LDL-C | Basseline to 44 weeks | No |
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