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| Sponsored by: |
Kowa Research Europe |
|---|---|
| Information provided by: | Kowa Research Europe |
| ClinicalTrials.gov Identifier: | NCT00309738 |
Purpose
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Dyslipidemia |
Drug: pitavastatin Drug: simvastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| CCBR a/S | |
| Aalborg, Denmark | |
| CCBR a/S | |
| Vejle, Denmark | |
| CCBR a/S | |
| Ballerup, Denmark | |
| Kolesterollaboratoriet | |
| Hellerup, Denmark | |
| Y Forskning, Bispebjerg Hospital | |
| Copenhagen NV, Denmark | |
| Frederiks Hospital, Kardiologisk | |
| Frederiksberg, Denmark | |
| Netherlands | |
| Mathenesserlaan 247 | |
| Rotterdam, Netherlands | |
| Damsterdiep 9 | |
| Groningen, Netherlands | |
| Parkdreef 142 | |
| Zoetermeer, Netherlands | |
| Reigerstraat 30 | |
| Velp, Netherlands | |
| Doezastraat 1 | |
| Leiden, Netherlands | |
| Kamerlingh Onnesstraat 16-18 | |
| Nijmegen, Netherlands | |
| Middellaan 5 | |
| Breda, Netherlands | |
| Bomanshof 8 | |
| Eindhoven, Netherlands | |
| Spain | |
| Hospital Universitario de Bellvitge | |
| Barcelona, Spain | |
| Hospital Clinico Universitario de Santiago | |
| Santiago de Compostela, Spain | |
| Hospital de Sagunto | |
| Valencia, Spain | |
| Hospital Universitario Reina Sofia | |
| Cordoba, Spain | |
| Fundacion Jimenez Diaz | |
| Madrid, Spain | |
| Hospital Clinico San Carlos | |
| Madrid, Spain | |
| Hospital Ramon y Cajal | |
| Madrid, Spain | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain | |
| Spain, Alicante | |
| Hospital Clinico S. Juan de Alicante | |
| San Juan, Alicante, Spain | |
| Spain, Barcelona | |
| Hospital Clinic i Provincial | |
| Villaroel, Barcelona, Spain | |
| Sweden | |
| Karolinska Universitetssjukhuset | |
| Stockholm, Sweden | |
| Medicinkliniken | |
| Ludvika, Sweden | |
| Sahlgrenska University Hospital, Intermedicin | |
| Gothenburg, Sweden | |
| Hjartmottagningen | |
| Malmo, Sweden | |
| Narsjukhuset Sandviken, Kardiologlab, Medicin | |
| Sandviken, Sweden | |
| Hjarthuset AB | |
| Varberg, Sweden | |
| Hjartmottagningen | |
| Helsingborg, Sweden | |
| Lakarcentrum Nyponet | |
| Karineholm, Sweden | |
| Hjart & Karlcenter | |
| Sodertalje, Sweden | |
| Huslakaren i Sandviken | |
| Sandviken, Sweden | |
| Angelholms Sjukhus, Medicinkliniken | |
| Angelhom, Sweden | |
| Study Director: | Dragos Budinski, Med Dr. | Medical Director |
More Information
| Study ID Numbers: | NK-104-304 |
| Study First Received: | December 8, 2005 |
| Last Updated: | October 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00309738 |
| Health Authority: | Sweden: Medical Products Agency; Spain: Spanish Agency of Medicines |
|
Kowa KRE Hypercholesterolemia combined dyslipidemia |
dyslipidemia pitavastatin NK-104 simvastatin |
|
Coronary Disease Metabolic Diseases Hyperlipidemias Heart Diseases NK 104 Simvastatin |
Metabolic disorder Hypercholesterolemia Dyslipidemias Coronary Artery Disease Lipid Metabolism Disorders |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
