Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
This study has been completed.
Sponsor:
Kowa Research Europe
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00344370
First received: June 23, 2006
Last updated: January 25, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type II Diabetes Mellitus Dyslipidemia |
Drug: Pitavastatin Drug: Atorvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Kowa Research Europe:
Primary Outcome Measures:
- NCEP LDL-C Target Attainment [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent Change From Baseline in LDL-C [ Time Frame: Basseline to 44 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 214 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pitavastatin
Pitavastatin 4 mg QD
|
Drug: Pitavastatin
Pitavastatin 4 mg QD
Other Name: Livalo
|
|
Active Comparator: Atorvastatin
Atorvastatin 40 mg
|
Drug: Atorvastatin
Atorvastatin 40 mg
Other Name: Lipitor
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type II diabetes mellitus
- Combined dyslipidemia
- Completed NK-104-305 (NCT00309751)
Exclusion Criteria:
- Withdrawal from NK-104-305 (NCT00309751)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344370
Locations
| Denmark | |
| CCBR Aalborg | |
| Aalborg, Denmark | |
| CCBR A/S | |
| Vejle, Denmark | |
| CCBR Vejle | |
| Vejle, Denmark | |
| 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, Germany | |
| 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, India | |
| 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, Netherlands | |
| 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, Poland | |
| 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, United Kingdom | |
Sponsors and Collaborators
Kowa Research Europe
Investigators
| Study Director: | Dragos Budinski, MD | Kowa Research Europe (KRE) |
More Information
No publications provided
| Responsible Party: | Dragos Budinski, MD, Kowa Research Europe |
| ClinicalTrials.gov Identifier: | NCT00344370 History of Changes |
| Other Study ID Numbers: | NK-104-310 |
| Study First Received: | June 23, 2006 |
| Results First Received: | September 1, 2009 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Poland: Ministry of Health Germany: Ethics Commission India: Indian Council of Medical Research |
Keywords provided by Kowa Research Europe:
|
Pitavastatin Type II Diabetes Mellitus Combined Dyslipidemia |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lipid Metabolism Disorders Atorvastatin Pitavastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013