Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
This study has been completed.
Sponsor:
Kowa Research Europe
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00257686
First received: November 21, 2005
Last updated: March 9, 2010
Last verified: March 2010
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Tracking Information | |||||
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First Received Date ICMJE | November 21, 2005 | ||||
Last Updated Date | March 9, 2010 | ||||
Start Date ICMJE | September 2005 | ||||
Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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) |
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Original Primary Outcome Measures ICMJE |
-reduction of LDL-C | ||||
Change History | Complete list of historical versions of study NCT00257686 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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) |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hypercholesterolemia or Combined Dyslipidemia | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 962 | ||||
Completion Date | May 2006 | ||||
Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Gender | Both | ||||
Ages | 65 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Denmark, Germany, Israel, Netherlands, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00257686 | ||||
Other Study ID Numbers ICMJE | NK-104-306 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Neil Hounslow, Kowa Research Europe | ||||
Study Sponsor ICMJE | Kowa Research Europe | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Kowa Research Europe | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |