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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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18 February 2013 |
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Main ID: |
NCT01239992 |
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Date of registration:
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12/11/2010 |
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Primary sponsor: |
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Public title:
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Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
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Scientific title:
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Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01239992 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Klaus Parhofer, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male subjects or postmenopausal female subjects aged between 19-70 years
- High risk patients (PROCAM risk =20%) on a stable statin-therapy, but at least
simvastatin 20 mg/d
- HDL-cholesterol =50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol
70 - 150 mg/dl
- Lipoprotein (a) < 30 mg/dl
- Patients may have normal glucose metabolism (normal HOMA), be insulin resistant
(abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not
diabetes mellitus.
- Without niacin therapy for at least 6 months
- Dosage of any concomitant medication has been stable for at least 3 weeks
- If female, postmenopausal (absence of menstruation for at least 12 months or absence
of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml)
Exclusion Criteria:
- Subjects with additional causes for hyperlipoproteinemia
- Diabetes mellitus or antidiabetic medication
- Subject has history of cardiovascular ischemia in previous 3 months or acute
myocardial infarction or unstable angina
- History of psychiatric disorder or cognitive impairment that would interfere with
participation in the study
- History of alcoholism
- Contraindication against niacin and/or laropiprant
- Subject has participated in an investigational study within 30 days prior to study
initiation
- Fasting triglycerides >400 mg/dl
- Life-threatening disease (e.g. cancer)
- Renal insufficiency (GFR = 30 ml/min )
- Major hepatic impairment
- Known allergic reaction/intolerance against niacin and/or laropiprant
- Active peptic ulcer disease
Age minimum:
19 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperlipoproteinemia
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Metabolic Syndrome
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Intervention(s)
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Drug: Niacin/ Laropiprant
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Primary Outcome(s)
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incremental area under the plasma triglyceride curve over 8 hours following a standardized oral fat tolerance test
[Time Frame: 12 weeks after treatment]
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Secondary Outcome(s)
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fasting lipid parameters
[Time Frame: 12 weeks after treatment]
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HDL metabolism
[Time Frame: 12 weeks after treatment]
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Secondary ID(s)
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2010-019954-42
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KP-Niacin-2010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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