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

March 9, 2010 updated by: Kowa Research Europe

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

962

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • CCBR A/S
      • Copenhagen, Denmark
        • Copenhagen University Hospital
      • Copenhagen, Denmark
        • Medical Center
      • Vejle, Denmark
        • CCBR A/S
  • Germany
      • Bad Soden / Taunus, Germany
        • Kardiologische Gemeinschaftspraxis Prof. Reifart
      • Beckum, Germany
        • Praxis Dr. Boenninghoff
      • Berlin, Germany
        • Klinische Forschung Berlin Mitte
      • Dresden, Germany
        • GWT-TUK mbH, Zentrum fur Klinische Studien
      • Goch, Germany
        • Gemeinschaftspraxis Dr. Krause, Th. Menke
      • Hamburg, Germany
        • Klinische Forschung Hamburg
      • Heidelberg, Germany
        • Innere Medizin I / Medizinische Klinik
      • Lampertheim, Germany
        • Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
      • Leipzig, Germany
        • ZET-Studien GmbH Leipzing
      • Mainz, Germany
        • Internistische Gemeinschaftspraxis
      • Mannheim, Germany
        • Praxis Dr. Wachter
      • Melcherstaette, Germany
        • Gemeinschaftspraxis Melcherstaette
      • Messkirch, Germany
        • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
      • Offenbach/M, Germany
        • Praxisgemeinschaft im Kleinen Biergrund
      • Stuhr-Brinkum, Germany
        • Gemeinschaftspraxis Melcherstaette
      • Weinheim, Germany
        • Gemeinschaftspraxis Drs. Mockesch
      • Wiesbaden, Germany
        • Intermed Institud fur Klinische Forschung und Arzn
      • Worpswede, Germany
        • Gemeinschaftspraxis Dr. Emden, Frank Drewes
  • Israel
      • Beersheva, Israel
        • Department of Internal Medicine, Soroka Medical Center
      • Haifa, Israel
        • Department of Internal Medicine A, Rambal Medical Center
      • Holon, Israel
        • Department of Internal Medicine, Wolfson Medical Center
      • Jerusalem Ein Kerem, Israel
        • Center for Research, Hadassah University Hospital
      • Kfar Saba, Israel
        • Meir Hospital
      • Mount Scopus Jerusalem, Israel
        • Department of Medicine, Hadassah Medical Center
      • Safed, Israel
        • Department of Internal Medicine, Rivka Sieff Medical Center
      • Tel Aviv, Israel
        • Institute of Metabolic Diseases
      • Tel Hashomer, Israel
        • Institue of Lipid & Atherosclerosis Research
  • Netherlands
      • ES Velp, Netherlands
        • Andromed Oost
      • Groningen, Netherlands
        • Andromed Noord
      • Hoorn, Netherlands
        • Vasculair Onderzoek Centrum Hoorn
      • Leiden, Netherlands
        • Andromed Leiden
      • Rotterdam, Netherlands
        • Andromed Rotterdam
      • Rotterdam, Netherlands
        • Andromed Nijmegen
      • Sliedrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • VL Breda, Netherlands
        • Andromed Breda
      • WP Tiel, Netherlands
        • Rivierenland Tiel
      • Zoetermeer, Netherlands
        • Andromed Zoetermeer
      • Zwijndrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
  • United Kingdom
      • Bath, United Kingdom
        • Oldfield Surgery
      • Bath, United Kingdom
        • St James's Surgery
      • Bath, United Kingdom
        • The Pulteney Practice
      • Birmingham, United Kingdom
        • Birmingham Clinical Research Centre
      • Bolton, United Kingdom
        • Stonehill Medical Center
      • Chorley, United Kingdom
        • Chorley Clinical Research Centre
      • Cornwall, United Kingdom
        • Saltash Health Center
      • Dronfield, United Kingdom
        • Gomersal Lane Surgery
      • Irvine, United Kingdom
        • Townhead Research
      • Liverpool, United Kingdom
        • Crosby Clinical Research Centre
      • Maidenhead, United Kingdom
        • The Symons Medical Center
      • Manchester, United Kingdom
        • Manchester Clinical Research Centre
      • Nottingham, United Kingdom
        • Greenwood Medical Center
      • Reading, United Kingdom
        • Reading Clinical Research Centre
      • Sheffield, United Kingdom
        • Elm Lane Surgery
      • Southampton, United Kingdom
        • Brook Lane Surgery
      • Wiltshire, United Kingdom
        • Bradford Road Medical Center
      • Wiltshire, United Kingdom
        • Rowden Medical Partnership
      • Wiltshire, United Kingdom
        • The Porch Surgery
      • Yorkshire, United Kingdom
        • The Burns Medical Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C
Time Frame: Baseline to 12 weeks
Percent change from baseline in low density cholesterol (LDL-C)
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in TC
Time Frame: Baseline to 12 weeks
Percent change from baseline in total cholesterol (TC)
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Europe

Investigators

  • Study Director: Dragos Budinski, MD, Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 23, 2005

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 9, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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