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)
Sponsor:
Information provided by (Responsible Party):
Klaus Parhofer, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01239992
First received: November 12, 2010
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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
Hyperlipoproteinemia
Metabolic Syndrome
Drug: Niacin/ Laropiprant
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    Percent change of incremental AUC at 12 weeks compared to baseline.


Secondary Outcome Measures:
  • HDL Cholesterol [ Time Frame: baseline and 12 weeks after treatment ] [ Designated as safety issue: No ]
    Percent change of HDL-cholesterol at 12 weeks compared to baseline.

  • Fasting Triglycerides [ Time Frame: baseline and 12 weeks after treatment ] [ Designated as safety issue: No ]
    Percent change of fasting triglycerides at 12 weeks compared to baseline


Other Outcome Measures:
  • LDL-cholesterol [ Time Frame: baseline and 12 weeks after treatment ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239992

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

No publications provided

Responsible Party: Klaus Parhofer, Professor of Medicine, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01239992     History of Changes
Other Study ID Numbers: KP-Niacin-2010, 2010-019954-42
Study First Received: November 12, 2010
Results First Received: December 2, 2013
Last Updated: March 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hyperlipoproteinemias
Metabolic Syndrome X
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Niacin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014