Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309738
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : January 18, 2010
Last Update Posted : March 16, 2010
Information provided by:
Kowa Research Europe

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemia Drug: pitavastatin Drug: simvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: pitavastatin
Active Comparator: Simvastatin 40 mg QD
Simvastatin 40 mg once daily
Drug: simvastatin

Primary Outcome Measures :
  1. Percent Change From Baseline in LDL-C [ Time Frame: 12 weeks ]
    Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures :
  1. Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) [ Time Frame: 12 weeks ]
    Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309738

Aalborg, Denmark
Ballerup, Denmark
Y Forskning, Bispebjerg Hospital
Copenhagen NV, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Hellerup, Denmark
Vejle, Denmark
Middellaan 5
Breda, Netherlands
Bomanshof 8
Eindhoven, Netherlands
Damsterdiep 9
Groningen, Netherlands
Doezastraat 1
Leiden, Netherlands
Kamerlingh Onnesstraat 16-18
Nijmegen, Netherlands
Mathenesserlaan 247
Rotterdam, Netherlands
Reigerstraat 30
Velp, Netherlands
Parkdreef 142
Zoetermeer, Netherlands
Hospital Clinico S. Juan de Alicante
San Juan, Alicante, Spain
Hospital Clinic i Provincial
Villaroel, Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, 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 Clinico Universitario de Santiago
Santiago de Compostela, Spain
Hospital de Sagunto
Valencia, Spain
Angelholms Sjukhus, Medicinkliniken
Angelhom, Sweden
Sahlgrenska University Hospital, Intermedicin
Gothenburg, Sweden
Helsingborg, Sweden
Lakarcentrum Nyponet
Karineholm, Sweden
Ludvika, Sweden
Malmo, Sweden
Huslakaren i Sandviken
Sandviken, Sweden
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken, Sweden
Hjart & Karlcenter
Sodertalje, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Hjarthuset AB
Varberg, Sweden
Sponsors and Collaborators
Kowa Research Europe
Study Director: Dragos Budinski, Med Dr. Medical Director

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Neil Hounslow, Kowa Research Europe Identifier: NCT00309738     History of Changes
Other Study ID Numbers: NK-104-304
First Posted: April 3, 2006    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010

Keywords provided by Kowa Research Europe:
combined dyslipidemia

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors