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Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients

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ClinicalTrials.gov Identifier: NCT00257686
Recruitment Status : Completed
First Posted : November 23, 2005
Results First Posted : January 18, 2010
Last Update Posted : March 16, 2010
Sponsor:
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 pravastatin in elderly patients

Condition or disease Intervention/treatment Phase
Hypercholesterolemia or Combined Dyslipidemia Drug: Pitavastatin Drug: Pravastatin Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Of Pitavastatin 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
Study Start Date : September 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pitavastatin 1 mg
Pitavastatin 1 mg once daily
Drug: Pitavastatin
Active Comparator: Pravastatin 10 mg
Pravastatin 10 mg once daily
Drug: Pravastatin
Experimental: Pitavastatin 2 mg
Pitavastatin 2 mg once daily
Drug: Pitavastatin
Active Comparator: Pravastatin 20 mg
Pravastatin 20 mg once daily
Drug: Pravastatin
Experimental: Pitavastatin 4 mg
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Active Comparator: Pravastatin 40 mg
Pravastatin 40 mg once daily
Drug: Pravastatin



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


Secondary Outcome Measures :
  1. Percent Change From Baseline in TC [ Time Frame: Baseline to 12 weeks ]
    Percent change from baseline in total cholesterol (TC)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and postmenopausal females (aged 65 years and older
  • Eligible, able to participate, have given informed consent
  • Must have been following a restrictive diet
  • Diagnosis of primary hypercholesterolemia or combined dyslipidemia
  • Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
  • Agree to be available

Exclusion Criteria

  • Homozygous familial hypercholesterolemia
  • Conditions which may cause secondary dyslipidemia
  • Uncontrolled diabetes mellitus (HbA1c >8%).
  • Any 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
  • Serum CK >5 x ULRR without clinical explanation
  • Uncontrolled hypothyroidism defined as TSH >ULRR
  • Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
  • Major surgery, 3 months prior to Visit 1
  • Significant 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 ejection fraction <0.25;
  • History of symptomatic cerebrovascular disease
  • Any other conditions at the discretion of the investigator
  • Known HIV infection
  • Poorly controlled or uncontrolled hypertension
  • Prior or current 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
  • History of hypersensitivity 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
  • Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.

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 ClinicalTrials.gov identifier (NCT number): NCT00257686


  Show 62 Study Locations
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, MD Medical Director

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neil Hounslow, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00257686     History of Changes
Other Study ID Numbers: NK-104-306
First Posted: November 23, 2005    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:
Kowa
Hypercholesterolemia
combined
dyslipidemia
elderly
pitavastatin
NK-104

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