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

NCT01239992 | Terminated Phase 4 Results

• 2 other identifiers: KP-Niacin-20102010-019954-42
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 12 weeks after treatment

Secondary Outcomes (2)

• HDL Cholesterol

  baseline and 12 weeks after treatment

• Fasting Triglycerides

  baseline and 12 weeks after treatment

Other Outcomes (1)

• LDL-cholesterol

  baseline and 12 weeks after treatment

Study Arms (1)

Niacin/ Laropiprant

EXPERIMENTAL

Drug: Niacin/ Laropiprant

Interventions

Niacin/ Laropiprant DRUG

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

Also known as: Tredaptive, EU/1/08/459/001

Niacin/ Laropiprant

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Hyperlipoproteinemias; Metabolic Syndrome

Interventions

Niacin; MK-0524

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Klaus G. Parhofer
• Organization: University Munich

klaus.parhofer@med.uni-muenchen.de

+49-89-7095-3010

Study Officials

• Klaus Parhofer, MD, Prof.

  Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 15, 2010
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 10, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-03

Locations

DE (1)