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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00257686
First received: November 21, 2005
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients


Condition Intervention Phase
Hypercholesterolemia or Combined Dyslipidemia
Drug: Pitavastatin
Drug: Pravastatin
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 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

Resource links provided by NLM:


Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Percent Change From Baseline in LDL-C [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in low density cholesterol (LDL-C)


Secondary Outcome Measures:
  • Percent Change From Baseline in TC [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in total cholesterol (TC)


Enrollment: 962
Study Start Date: September 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00257686

  Show 62 Study Locations
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, MD 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: NCT00257686     History of Changes
Other Study ID Numbers: NK-104-306
Study First Received: November 21, 2005
Results First Received: August 26, 2009
Last Updated: March 9, 2010
Health Authority: Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Israel: Israeli Health Ministry Pharmaceutical Administration
Netherlands: Dutch Health Care Inspectorate
United Kingdom: National Health Service

Keywords provided by Kowa Research Europe:
Kowa
Hypercholesterolemia
combined
dyslipidemia
elderly
pitavastatin
NK-104

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

ClinicalTrials.gov processed this record on September 22, 2014