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

Primary Purpose

Hyperlipoproteinemia, Metabolic Syndrome

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Niacin/ Laropiprant
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipoproteinemia

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Niacin/ Laropiprant

Arm Description

Outcomes

Primary Outcome Measures

Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
Percent change of incremental AUC at 12 weeks compared to baseline.

Secondary Outcome Measures

HDL Cholesterol
Percent change of HDL-cholesterol at 12 weeks compared to baseline.
Fasting Triglycerides
Percent change of fasting triglycerides at 12 weeks compared to baseline

Full Information

First Posted
November 12, 2010
Last Updated
March 12, 2014
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01239992
Brief Title
Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Official Title
Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
negative endpoint study resulting in withdrawal of study drug
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipoproteinemia, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niacin/ Laropiprant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Niacin/ Laropiprant
Other Intervention Name(s)
Tredaptive, EU/1/08/459/001
Intervention Description
1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Primary Outcome Measure Information:
Title
Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
Description
Percent change of incremental AUC at 12 weeks compared to baseline.
Time Frame
baseline and 12 weeks after treatment
Secondary Outcome Measure Information:
Title
HDL Cholesterol
Description
Percent change of HDL-cholesterol at 12 weeks compared to baseline.
Time Frame
baseline and 12 weeks after treatment
Title
Fasting Triglycerides
Description
Percent change of fasting triglycerides at 12 weeks compared to baseline
Time Frame
baseline and 12 weeks after treatment
Other Pre-specified Outcome Measures:
Title
LDL-cholesterol
Description
Percent change of LDL-cholesterol at 12 weeks compared to baseline
Time Frame
baseline and 12 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Parhofer, MD, Prof.
Organizational Affiliation
Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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