Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01239992
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01239992
Study Brief:
Protocol Section:
NCT01239992