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

This study has been terminated.
(negative endpoint study resulting in withdrawal of study drug)
Information provided by (Responsible Party):
Klaus Parhofer, Ludwig-Maximilians - University of Munich Identifier:
First received: November 12, 2010
Last updated: March 12, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Metabolic Syndrome
Drug: Niacin/ Laropiprant
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia

Resource links provided by NLM:

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test [ Time Frame: baseline and 12 weeks after treatment ]
    Percent change of incremental AUC at 12 weeks compared to baseline.

Secondary Outcome Measures:
  • HDL Cholesterol [ Time Frame: baseline and 12 weeks after treatment ]
    Percent change of HDL-cholesterol at 12 weeks compared to baseline.

  • Fasting Triglycerides [ Time Frame: baseline and 12 weeks after treatment ]
    Percent change of fasting triglycerides at 12 weeks compared to baseline

Other Outcome Measures:
  • LDL-cholesterol [ Time Frame: baseline and 12 weeks after treatment ]
    Percent change of LDL-cholesterol at 12 weeks compared to baseline

Enrollment: 12
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niacin/ Laropiprant Drug: Niacin/ Laropiprant
1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Other Names:
  • Tredaptive
  • EU/1/08/459/001


Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01239992

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Principal Investigator: Klaus Parhofer, MD, Prof. Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
  More Information

Responsible Party: Klaus Parhofer, Professor of Medicine, Ludwig-Maximilians - University of Munich Identifier: NCT01239992     History of Changes
Other Study ID Numbers: KP-Niacin-2010
2010-019954-42 ( EudraCT Number )
Study First Received: November 12, 2010
Results First Received: December 2, 2013
Last Updated: March 12, 2014

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on May 23, 2017