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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01239992
Other study ID # KP-Niacin-2010
Secondary ID 2010-019954-42
Status Terminated
Phase Phase 4
First received November 12, 2010
Last updated March 12, 2014
Start date June 2011
Est. completion date July 2013

Study information

Verified date March 2014
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date July 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Niacin/ Laropiprant
1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily

Locations

Country Name City State
Germany Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern Munich

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other LDL-cholesterol Percent change of LDL-cholesterol at 12 weeks compared to baseline baseline and 12 weeks after treatment No
Primary 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 No
Secondary HDL Cholesterol Percent change of HDL-cholesterol at 12 weeks compared to baseline. baseline and 12 weeks after treatment No
Secondary Fasting Triglycerides Percent change of fasting triglycerides at 12 weeks compared to baseline baseline and 12 weeks after treatment No
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