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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00309738
First received: December 8, 2005
Last updated: March 9, 2010
Last verified: March 2010
History of Changes
  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 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: 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:

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 ]
    Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)


Secondary Outcome Measures:
  • Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)


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
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

  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
Ballerup, Denmark
Y Forskning, Bispebjerg Hospital
Copenhagen NV, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Kolesterollaboratoriet
Hellerup, Denmark
CCBR A/S
Vejle, Denmark
Netherlands
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
Spain
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
Hospital Clinico San Carlos
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Hospital de Sagunto
Valencia, Spain
Sweden
Angelholms Sjukhus, Medicinkliniken
Angelhom, Sweden
Sahlgrenska University Hospital, Intermedicin
Gothenburg, Sweden
Hjartmottagningen
Helsingborg, Sweden
Lakarcentrum Nyponet
Karineholm, Sweden
Medicinkliniken
Ludvika, Sweden
Hjartmottagningen
Malmo, Sweden
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken, Sweden
Huslakaren i Sandviken
Sandviken, Sweden
Hjart & Karlcenter
Sodertalje, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Hjarthuset AB
Varberg, Sweden
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, Med Dr. Medical Director
  More Information

No publications provided by Kowa Research Europe

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Neil Hounslow, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00309738     History of Changes
Other Study ID Numbers: NK-104-304
Study First Received: December 8, 2005
Results First Received: August 26, 2009
Last Updated: March 9, 2010
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:
Coronary Disease
Hypercholesterolemia
Dyslipidemias
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
 Pitavastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013