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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00330876 |
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Date of registration:
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26/05/2006 |
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Primary sponsor: |
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Public title:
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Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
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Scientific title:
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Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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545 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00330876 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Germany
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Israel
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Netherlands
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United Kingdom
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Contacts
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Name:
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Dragos Budinski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Director |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Greater than or equal to 65 years of age
- Primary hypercholesterolemia
- Combined dyslipidemia
- Completed study NK-104-306 (NCT00257686)
Exclusion Criteria:
- Failed to complete study NK-104-306(NCT00257686)
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dyslipidemias
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Hypercholesterolemia
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Intervention(s)
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Drug: Pitavastatin
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Primary Outcome(s)
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Change From Baseline in LDL-C
[Time Frame: Baseline to 60 weeks]
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Secondary Outcome(s)
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Change From Baseline in Total Cholesterol
[Time Frame: Baseline to 60 weeks]
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Secondary ID(s)
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NK-104-308EU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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