Status:
TERMINATED
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (L...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- LMT ineligible
- Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
- HDL-C \<40 mg/dL (1.03 mmol/L) in males and \<50 mg/dL (1.29 mmol/L) in females
- Triglyceride (TG) level \<300 mg/dL (3.39 mmol/L).
- Fasting serum glucose (FSG) at Visit 1 AND Visit 2 \<126 mg/dL (\<7 mmol/L)
- Hemoglobin A1c (HbA1c) level \<6.5%
- Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period
- Exclusion criteria:
- History of malignancy ≤5 years prior to signing informed consent, except for adequately-treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
- Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
- Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
- Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study
- Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%
- Risk factors for coronary heart disease
- Active or chronic hepatobiliary or hepatic disease
- Active peptic ulcer disease within 3 months of Visit 1
- History of hypersensitivity or allergic reaction to niacin or niacin-containing products
- Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol
- Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin \>50 mg as monotherapy or coadministered with other LMTs)
- Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering
- Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)
- Uncontrolled illness or infection
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01414166
Start Date
September 1 2011
End Date
February 1 2013
Last Update
May 13 2015
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