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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00249249
First received: November 4, 2005
Last updated: January 7, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Primary Hypercholesterolemia
Dyslipidemia
Drug: Pitavastatin
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
  • TC:HDL-C Ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Triglycerides (TG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Non-HDL:HDL Ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B (Apo B) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein-A1 (Apo-A1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Apo-B:Apo-A1 Ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Oxidized LDL at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • National Cholesterol Education Program [NCEP]LDL-C Target Attainment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 830
Study Start Date: October 2005
Study Completion Date: November 2006
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.

  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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249249

  Show 192 Study Locations
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, Med Dr. Kowa Research Europe
  More Information

No publications provided

Responsible Party: Neil Hounslow, MD, Kowa Research Europe, Ltd.
ClinicalTrials.gov Identifier: NCT00249249     History of Changes
Other Study ID Numbers: NK-104-301, EudraCT number 2005-001000-39
Study First Received: November 4, 2005
Results First Received: August 26, 2009
Last Updated: January 7, 2010
Health Authority: Spain: Spanish Agency of Medicines
India: Indian Council of Medical Research
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Kowa Research Europe:
hypercholesterolemia
dyslipidemia
kowa
KRE
pitavastatin
NK-104

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Pitavastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014