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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01239992
Recruitment Status : Terminated (negative endpoint study resulting in withdrawal of study drug)
First Posted : November 15, 2010
Results First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Klaus Parhofer, Ludwig-Maximilians - University of Munich

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperlipoproteinemia Metabolic Syndrome Drug: Niacin/ Laropiprant Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia
Study Start Date : June 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. HDL Cholesterol [ Time Frame: baseline and 12 weeks after treatment ]
    Percent change of HDL-cholesterol at 12 weeks compared to baseline.

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


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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239992


Locations
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Germany
Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Klaus Parhofer, MD, Prof. Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
More Information
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Responsible Party: Klaus Parhofer, Professor of Medicine, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01239992    
Other Study ID Numbers: KP-Niacin-2010
2010-019954-42 ( EudraCT Number )
First Posted: November 15, 2010    Key Record Dates
Results First Posted: April 10, 2014
Last Update Posted: April 10, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Metabolic Syndrome
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Niacin
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs