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

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01239992
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipoproteinemia; Metabolic Syndrome	Drug: Niacin/ Laropiprant	Phase 4

Study Design

• Study Type: Interventional
• 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: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Primary Outcome Measures

1. Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test [baseline and 12 weeks after treatment]

   Percent change of incremental AUC at 12 weeks compared to baseline.

Secondary Outcome Measures

1. HDL Cholesterol [baseline and 12 weeks after treatment]

   Percent change of HDL-cholesterol at 12 weeks compared to baseline.

2. Fasting Triglycerides [baseline and 12 weeks after treatment]

   Percent change of fasting triglycerides at 12 weeks compared to baseline

Other Outcome Measures

1. LDL-cholesterol [baseline and 12 weeks after treatment]

   Percent change of LDL-cholesterol at 12 weeks compared to baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• First Posted: Nov 15, 2010
• Last Update Posted: Apr 10, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Metabolic Syndrome; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Niacin

Study Results

Participant Flow

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Period Title: Overall Study
STARTED	12
COMPLETED	10
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (9)
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	12 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Germany	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Measure Participants	10
Mean (Standard Deviation) [percentage change]	-28 (5)

2. Secondary Outcome

Title	HDL Cholesterol
Description	Percent change of HDL-cholesterol at 12 weeks compared to baseline.
Time Frame	baseline and 12 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Measure Participants	10
Mean (Standard Deviation) [percentage change]	17 (6)

3. Secondary Outcome

Title	Fasting Triglycerides
Description	Percent change of fasting triglycerides at 12 weeks compared to baseline
Time Frame	baseline and 12 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Measure Participants	10
Mean (Standard Deviation) [percentage change]	-26 (15)

4. Other Pre-specified Outcome

Title	LDL-cholesterol
Description	Percent change of LDL-cholesterol at 12 weeks compared to baseline
Time Frame	baseline and 12 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Measure Participants	10
Mean (Standard Deviation) [percentage change]	-20 (8)

Adverse Events

Arm/Group Title	Niacin/ Laropiprant
Arm/Group Description	Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
All Cause Mortality
	Niacin/ Laropiprant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Niacin/ Laropiprant
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Niacin/ Laropiprant
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.