Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors - Full Text View

Sponsored by:	Kowa Research Europe
Information provided by:	Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT00344175

Purpose

This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Condition	Intervention	Phase
Hypercholesterolemia Dyslipidemia Coronary Heart Disease	Drug: pitavastatin Drug: simvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin Pitavastatin NK 104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind Follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-Blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:

Low density lipoprotein-cholesterol (LDL-C) target attainment (European Atherosclerosis Society [EAS] and National Cholesterol Education Program [NCEP] criteria) at 16 and 44 weeks

Secondary Outcome Measures:

Low density lipoprotein-cholesterol (LDL-C)
Total cholesterol (TC)
High density lipoprotein-cholesterol (HDL-C)
TC:HDL-C ratio
Triglycerides (TG)
Non-HDL:HDL ratio
Apo-A1
Apo-B
Apo-B:Apo-A1 ratio
High sensitivity C-reactive protein (hs-CRP) and oxidized LDL

Estimated Enrollment:	270
Study Start Date:	June 2006
Study Completion Date:	March 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completed NK-104-304
Hypercholesterolemia or combined dyslipidemia
2 or more risk factors for coronary heart disease (CHD)

Exclusion Criteria:

Withdrawn or terminated from NK-104-304

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344175

Locations

Denmark
CCBR a/S
Vejle, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Kolesterollaboratoriet
Hellerup, Denmark
Y Forskning, Bispebjerg Hospital
Copenhagen NV, Denmark
Netherlands
Bomanshof 8
Eindhoven, Netherlands
Damsterdiep 9
Groningen, Netherlands
Doezastraat 1
Leiden, Netherlands
Kamerlingh Onnesstraat 16-18
Nijmegen, Netherlands
Mathenesserlaan 247
Rotterdam, Netherlands
Middellaan 5
Breda, Netherlands
Parkdreef 142
Zoetermeer, Netherlands
Reigerstraat 30
Velp, Netherlands
Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Hospital Ramon y Cajal
Madrid, Spain, 28000
Hospital Universitario Reina Sofia
Cordoba, Spain
Spain, Alicante
Hospital Clinico S. Juan de Alicante
San Juan, Alicante, Spain
Sweden
Angelholms Sjukhus, Medicinkliniken
Angelhom, Sweden
Hjart & Karlcenter
Sodertalje, Sweden
Hjarthuset AB
Varberg, Sweden
Sahlgrenska University Hospital, Intermedicin
Gothenburg, Sweden
Huslakaren i Sandviken
Sandviken, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Lakarcentrum Nyponet
Karineholm, Sweden
Medicinkliniken
Ludvika, Sweden
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken, Sweden
Hjartmottagningen
Helsingborg, Sweden

Sponsors and Collaborators

Kowa Research Europe

Investigators

Study Director:

Dragos Budinski, MD

Kowa Research Europe

More Information

Responsible Party:	Kowa Research Europe ( Dragos Budinski )
Study ID Numbers:	NK-104-309
Study First Received:	June 22, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00344175
Health Authority:	Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency

Keywords provided by Kowa Research Europe:

hypercholesterolemia
dyslipidemia
CHD
pitavastatin

simvastatin
2 or more risk factors for coronary heart disease
combined dyslipidemia

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Simvastatin
Myocardial Ischemia
Vascular Diseases
Ischemia

Arteriosclerosis
Coronary Disease
NK 104
Metabolic disorder
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009