Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin - Full Text View

Sponsor:	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 (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Heart Diseases

Drug Information available for: Simvastatin Pitavastatin NK 104

U.S. FDA Resources

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:

Percent Change From Baseline in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Patients Attaining NCEP LDL-C Target [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	355
Study Start Date:	September 2005
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pitavastatin 4 mg QD: Experimental Pitavastatin 4 mg once daily	Drug: pitavastatin
Simvastatin 40 mg QD: Active Comparator Simvastatin 40 mg once daily	Drug: simvastatin

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females (18-75 years of age)
At least two cardiovascular disease risk factors
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus
Abnormal pancreatic, liver or renal function
Abnormal serum creatine kinase (CK) above the pre-specified level

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309738

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

Sponsors and Collaborators

Kowa Research Europe

Investigators

Study Director:

Dragos Budinski, Med Dr.

Medical Director

More Information

No publications provided

Responsible Party:	Kowa Research Europe ( Neil Hounslow )
Study ID Numbers:	NK-104-304
Study First Received:	December 8, 2005
Results First Received:	August 26, 2009
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00309738 History of Changes
Health Authority:	Sweden: Medical Products Agency; Spain: Spanish Agency of Medicines

Keywords provided by Kowa Research Europe:

Kowa
KRE
Hypercholesterolemia
combined dyslipidemia

dyslipidemia
pitavastatin
NK-104
simvastatin

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
NK 104
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 09, 2010