Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia

NCT ID: NCT01239992

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-07-31

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 of endothelial dysfunction and inflammation.

Conditions

Hyperlipoproteinemia; Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Niacin/ Laropiprant

Group Type: EXPERIMENTAL

Niacin/ Laropiprant

Intervention Type: DRUG

1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily

Interventions

Niacin/ Laropiprant

1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily

Intervention Type: DRUG

Other Intervention Names

Tredaptive; EU/1/08/459/001

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Klaus Parhofer

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus Parhofer, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

Locations

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

Munich, , Germany

Countries

Germany

Other Identifiers

2010-019954-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KP-Niacin-2010

Identifier Type: -

Identifier Source: org_study_id