Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoprote… (NCT01239992) | Clinical Trial Compass
TerminatedPhase 4
Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Stopped: negative endpoint study resulting in withdrawal of study drug
Germany12 participantsStarted 2011-06
Plain-language 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.
Who can participate
Age range
19 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 aller…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test