Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

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: NCT00249249
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : December 16, 2009
Last Update Posted : January 12, 2010
Information provided by:
Kowa Research Europe

Brief Summary:
The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Dyslipidemia Drug: Pitavastatin Drug: Atorvastatin Phase 3

Detailed Description:
Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Study of Pitavastatin 2 mg vs. Atorvastatin 10 mg and Pitavastatin 4 mg vs. Atorvastatin 20 mg (Following Up Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study Start Date : October 2005
Actual Study Completion Date : November 2006

Primary Outcome Measures :
  1. Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline to 12 Weeks ]
  2. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline to 12 weeks ]
  3. TC:HDL-C Ratio [ Time Frame: 12 weeks ]
  4. Triglycerides (TG) [ Time Frame: 12 weeks ]
  5. Non-HDL:HDL Ratio [ Time Frame: 12 weeks ]
  6. Apolipoprotein B (Apo B) [ Time Frame: 12 weeks ]
  7. Apolipoprotein-A1 (Apo-A1) [ Time Frame: 12 weeks ]
  8. Apo-B:Apo-A1 Ratio [ Time Frame: 12 weeks ]
  9. High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks [ Time Frame: 12 weeks ]
  10. Oxidized LDL at 12 Weeks [ Time Frame: 12 weeks ]
  11. National Cholesterol Education Program [NCEP]LDL-C Target Attainment [ Time Frame: up to 12 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Males and females (age 18-75 years).
  • Non-pregnant, non-lactating females
  • Women of child bearing potential should use sustained contraceptive preparations or an approved mechanical contraceptive method.
  • Eligible and able to participate and have given informed consent
  • Must have been following a restrictive diet and does not eat or drink grapefruit
  • Diagnosis of primary hypercholesterolemia or combined dyslipidemia
  • Available for every clinic visit, which will occur in the morning.

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia
  • Conditions which may cause secondary dyslipidemia.
  • Condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
  • History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
  • Liver injury
  • Impaired renal function
  • Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
  • Serum creatine kinase (CK) >5 x upper limit of the reference range (ULRR).
  • Uncontrolled hypothyroidism
  • Severe acute illness or severe trauma in the last 3 months
  • Major surgery, 3 months prior to Visit 1
  • Significant cardiovascular disease (CVD) prior to randomization
  • Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of >100 beats per minute at rest.
  • Left ventricular (LV) ejection fraction < 0.25
  • History of symptomatic cerebrovascular disease
  • Conditions at the discretion of the investigator
  • Known HIV infection
  • Poorly controlled or uncontrolled hypertension.
  • Known muscular or neuromuscular disease of any type
  • Neoplastic disease
  • Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
  • Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
  • Current or recent use of supplements known to alter lipid metabolism
  • Hypersensitivity reactions to other HMG-CoA reductase inhibitors
  • Concomitant medication not permitted
  • Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
  • Excessive obesity
  • Regular clinic attendance in the morning impractical
  • Signs of mental dysfunction or other factors likely to limit ability to cooperate

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): NCT00249249

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Sponsors and Collaborators
Kowa Research Europe
Study Director: Dragos Budinski, Med Dr. Kowa Research Europe

Responsible Party: Neil Hounslow, MD, Kowa Research Europe, Ltd. Identifier: NCT00249249     History of Changes
Other Study ID Numbers: NK-104-301
EudraCT number 2005-001000-39
First Posted: November 7, 2005    Key Record Dates
Results First Posted: December 16, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by Kowa Research Europe:

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