Status:
TERMINATED
Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Hyperlipoproteinemia
Metabolic Syndrome
Eligibility:
All Genders
19-70 years
Phase:
PHASE4
Brief Summary
The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01239992
Start Date
June 1 2011
End Date
July 1 2013
Last Update
April 10 2014
Active Locations (1)
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1
Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
Munich, Germany, 81377