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

Primary Purpose

Hypercholesterolemia or Combined Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pitavastatin
Pravastatin
Sponsored by
Kowa Research Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia or Combined Dyslipidemia focused on measuring Kowa, Hypercholesterolemia, combined, dyslipidemia, elderly, pitavastatin, NK-104

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CCBR A/S
  • Copenhagen University Hospital
  • Medical Center
  • CCBR A/S
  • Kardiologische Gemeinschaftspraxis Prof. Reifart
  • Praxis Dr. Boenninghoff
  • Klinische Forschung Berlin Mitte
  • GWT-TUK mbH, Zentrum fur Klinische Studien
  • Gemeinschaftspraxis Dr. Krause, Th. Menke
  • Klinische Forschung Hamburg
  • Innere Medizin I / Medizinische Klinik
  • Gemeinschaftspraxis H. Holz Dr. med, K. W. Klingl
  • ZET-Studien GmbH Leipzing
  • Internistische Gemeinschaftspraxis
  • Praxis Dr. Wachter
  • Gemeinschaftspraxis Melcherstaette
  • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
  • Praxisgemeinschaft im Kleinen Biergrund
  • Gemeinschaftspraxis Melcherstaette
  • Gemeinschaftspraxis Drs. Mockesch
  • Intermed Institud Fur Klinische Forschung und Arzn
  • Gemeinschaftspraxis Dr. Emden, Frank Drewes
  • Department of Internal Medicine, Soroka Medical Center
  • Department of Internal Medicine A, Rambal Medical Center
  • Department of Internal Medicine, Wolfson Medical Center
  • Center for Research, Hadassah University Hospital
  • Meir Hospital
  • Department of Medicine, Hadassah Medical Center
  • Department of Internal Medicine, Rivka Sieff Medical Center
  • Institute of Metabolic Diseases
  • Institue of Lipid & Atherosclerosis Research
  • Andromed Oost
  • Andromed Noord
  • Vasculair Onderzoek Centrum Hoorn
  • Andromed Leiden
  • Andromed Nijmegen
  • Andromed Rotterdam
  • Albert Schweitzer ziekenhuis
  • Andromed Breda
  • Rivierenland Tiel
  • Andromed Zoetermeer
  • Albert Schweitzer ziekenhuis
  • Oldfield Surgery
  • St James's Surgery
  • The Pulteney Practice
  • Birmingham Clinical Research Centre
  • Stonehill Medical Center
  • Chorley Clinical Research Centre
  • Saltash Health Center
  • Gomersal Lane Surgery
  • Townhead Research
  • Crosby Clinical Research Centre
  • The Symons Medical Center
  • Manchester Clinical Research Centre
  • Greenwood Medical Center
  • Reading Clinical Research Centre
  • Elm Lane Surgery
  • Brook Lane Surgery
  • Bradford Road Medical Center
  • Rowden Medical Partnership
  • The Porch Surgery
  • The Burns Medical Practice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Pitavastatin 1 mg

Pravastatin 10 mg

Pitavastatin 2 mg

Pravastatin 20 mg

Pitavastatin 4 mg

Pravastatin 40 mg

Arm Description

Pitavastatin 1 mg once daily

Pravastatin 10 mg once daily

Pitavastatin 2 mg once daily

Pravastatin 20 mg once daily

Pitavastatin 4 mg once daily

Pravastatin 40 mg once daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline in LDL-C
Percent change from baseline in low density cholesterol (LDL-C)

Secondary Outcome Measures

Percent Change From Baseline in TC
Percent change from baseline in total cholesterol (TC)

Full Information

First Posted
November 21, 2005
Last Updated
March 9, 2010
Sponsor
Kowa Research Europe
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1. Study Identification

Unique Protocol Identification Number
NCT00257686
Brief Title
Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
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 Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kowa Research Europe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia or Combined Dyslipidemia
Keywords
Kowa, Hypercholesterolemia, combined, dyslipidemia, elderly, pitavastatin, NK-104

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
962 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 1 mg
Arm Type
Experimental
Arm Description
Pitavastatin 1 mg once daily
Arm Title
Pravastatin 10 mg
Arm Type
Active Comparator
Arm Description
Pravastatin 10 mg once daily
Arm Title
Pitavastatin 2 mg
Arm Type
Experimental
Arm Description
Pitavastatin 2 mg once daily
Arm Title
Pravastatin 20 mg
Arm Type
Active Comparator
Arm Description
Pravastatin 20 mg once daily
Arm Title
Pitavastatin 4 mg
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Arm Title
Pravastatin 40 mg
Arm Type
Active Comparator
Arm Description
Pravastatin 40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C
Description
Percent change from baseline in low density cholesterol (LDL-C)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in TC
Description
Percent change from baseline in total cholesterol (TC)
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, MD
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
CCBR A/S
City
Aalborg
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Medical Center
City
Copenhagen
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
Country
Denmark
Facility Name
Kardiologische Gemeinschaftspraxis Prof. Reifart
City
Bad Soden / Taunus
Country
Germany
Facility Name
Praxis Dr. Boenninghoff
City
Beckum
Country
Germany
Facility Name
Klinische Forschung Berlin Mitte
City
Berlin
Country
Germany
Facility Name
GWT-TUK mbH, Zentrum fur Klinische Studien
City
Dresden
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Krause, Th. Menke
City
Goch
Country
Germany
Facility Name
Klinische Forschung Hamburg
City
Hamburg
Country
Germany
Facility Name
Innere Medizin I / Medizinische Klinik
City
Heidelberg
Country
Germany
Facility Name
Gemeinschaftspraxis H. Holz Dr. med, K. W. Klingl
City
Lampertheim
Country
Germany
Facility Name
ZET-Studien GmbH Leipzing
City
Leipzig
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Mainz
Country
Germany
Facility Name
Praxis Dr. Wachter
City
Mannheim
Country
Germany
Facility Name
Gemeinschaftspraxis Melcherstaette
City
Melcherstaette
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
City
Messkirch
Country
Germany
Facility Name
Praxisgemeinschaft im Kleinen Biergrund
City
Offenbach/M
Country
Germany
Facility Name
Gemeinschaftspraxis Melcherstaette
City
Stuhr-Brinkum
Country
Germany
Facility Name
Gemeinschaftspraxis Drs. Mockesch
City
Weinheim
Country
Germany
Facility Name
Intermed Institud Fur Klinische Forschung und Arzn
City
Wiesbaden
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Emden, Frank Drewes
City
Worpswede
Country
Germany
Facility Name
Department of Internal Medicine, Soroka Medical Center
City
Beersheva
Country
Israel
Facility Name
Department of Internal Medicine A, Rambal Medical Center
City
Haifa
Country
Israel
Facility Name
Department of Internal Medicine, Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Center for Research, Hadassah University Hospital
City
Jerusalem Ein Kerem
Country
Israel
Facility Name
Meir Hospital
City
Kfar Saba
Country
Israel
Facility Name
Department of Medicine, Hadassah Medical Center
City
Mount Scopus Jerusalem
Country
Israel
Facility Name
Department of Internal Medicine, Rivka Sieff Medical Center
City
Safed
Country
Israel
Facility Name
Institute of Metabolic Diseases
City
Tel Aviv
Country
Israel
Facility Name
Institue of Lipid & Atherosclerosis Research
City
Tel Hashomer
Country
Israel
Facility Name
Andromed Oost
City
ES Velp
Country
Netherlands
Facility Name
Andromed Noord
City
Groningen
Country
Netherlands
Facility Name
Vasculair Onderzoek Centrum Hoorn
City
Hoorn
Country
Netherlands
Facility Name
Andromed Leiden
City
Leiden
Country
Netherlands
Facility Name
Andromed Nijmegen
City
Rotterdam
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
Country
Netherlands
Facility Name
Albert Schweitzer ziekenhuis
City
Sliedrecht
Country
Netherlands
Facility Name
Andromed Breda
City
VL Breda
Country
Netherlands
Facility Name
Rivierenland Tiel
City
WP Tiel
Country
Netherlands
Facility Name
Andromed Zoetermeer
City
Zoetermeer
Country
Netherlands
Facility Name
Albert Schweitzer ziekenhuis
City
Zwijndrecht
Country
Netherlands
Facility Name
Oldfield Surgery
City
Bath
Country
United Kingdom
Facility Name
St James's Surgery
City
Bath
Country
United Kingdom
Facility Name
The Pulteney Practice
City
Bath
Country
United Kingdom
Facility Name
Birmingham Clinical Research Centre
City
Birmingham
Country
United Kingdom
Facility Name
Stonehill Medical Center
City
Bolton
Country
United Kingdom
Facility Name
Chorley Clinical Research Centre
City
Chorley
Country
United Kingdom
Facility Name
Saltash Health Center
City
Cornwall
Country
United Kingdom
Facility Name
Gomersal Lane Surgery
City
Dronfield
Country
United Kingdom
Facility Name
Townhead Research
City
Irvine
Country
United Kingdom
Facility Name
Crosby Clinical Research Centre
City
Liverpool
Country
United Kingdom
Facility Name
The Symons Medical Center
City
Maidenhead
Country
United Kingdom
Facility Name
Manchester Clinical Research Centre
City
Manchester
Country
United Kingdom
Facility Name
Greenwood Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
Reading Clinical Research Centre
City
Reading
Country
United Kingdom
Facility Name
Elm Lane Surgery
City
Sheffield
Country
United Kingdom
Facility Name
Brook Lane Surgery
City
Southampton
Country
United Kingdom
Facility Name
Bradford Road Medical Center
City
Wiltshire
Country
United Kingdom
Facility Name
Rowden Medical Partnership
City
Wiltshire
Country
United Kingdom
Facility Name
The Porch Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
The Burns Medical Practice
City
Yorkshire
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22679249
Citation
Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013 Feb;20(1):40-53. doi: 10.1177/2047487312451251. Epub 2012 Jun 7.
Results Reference
derived

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

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