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Main
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Note: This record shows only 22 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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19 October 2017 |
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Main ID: |
NCT00325780 |
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Date of registration:
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10/02/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-Term Extension Study of Pitavastatin in 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 Patients With Primary Hypercholesterolemia or Combined Dyslipidemia |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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1355 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00325780 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Finland
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Germany
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India
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Israel
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Italy
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Netherlands
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Norway
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Poland
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Russian Federation
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Dragos Budinski, Med Dr. |
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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:
- Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or
NK-104-302 (NCT00309777)
- Patients who have not developed any treatment emergent and, in the opinion of the
investigator, related adverse event (AE) of clinical significance where the
investigator is uncomfortable with continuing the patient on therapy with
pitavastatin.
- Patients who have been following a fat and cholesterol restrictive diet.
Exclusion Criteria:
- Any conditions which may cause secondary dyslipidemia should be reassessed at the
beginning of the follow-up study.
- Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up
study.
- Abnormal pancreatic, liver, or renal function
- Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the
pre-specified level
- Significant heart disease
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dyslipidemia
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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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Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
[Time Frame: Baseline to 52 Weeks]
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Secondary Outcome(s)
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Change From Baseline in Total Cholesterol
[Time Frame: Baseline to 52 weeks]
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Secondary ID(s)
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NK-104-307
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2005-001112-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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