A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: ER niacin (+) laropiprant (ERN/LRPT); ER niacin (+) laropiprant (ERN/LRPT); Extended-release niacin (ERN); Placebo to ERN/LRPT
Intervention description: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks; One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.; Two 1g tablets ERN (2g total) once daily for 12 weeks.; One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1152.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms
      beyond 6 months and will measure the impact of withdrawal of laropiprant in patients
      following 20 weeks of stable maintenance therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is a male, or a female who is unlikely to conceive, as indicated by meeting at
             least one of the following conditions: (a) Patient is a male.(b) Patient is a female
             of reproductive potential and either agrees to remain abstinent (if this form of birth
             control is accepted by local regulatory agencies and review committees as the sole
             method of birth control) or use (or have their partner use) 2 acceptable methods of
             birth control within the projected duration of the study.(c) Patient is a female who
             is not of reproductive potential and therefore eligible to participate in this study
             without requiring the use of contraception.

          -  Lipid-modifying therapy (LMT) is appropriate for the patient

          -  Patient meets one of the following criteria based on the National Cholesterol
             Education Program Adult Treatment Panel III guidelines : 1) High risk and is on a
             statin with LDL-cholesterol (LDL-C) <100 mg/dL or intolerant to statins with LDL-C
             <120 mg/dL; 2) Multiple risk with LDL-C <130 mg/dL; 3) Low risk with LDL-C <190 mg/dL

          -  Patient has triglyceride levels <500 mg/dL

        Exclusion Criteria:

          -  Patient is pregnant, breast-feeding, or expecting to conceive

          -  Patient has a history of cancer within 5 years of screening (except certain skin and
             cervical cancers)

          -  Female patient plans to donate eggs during the study

          -  Male patient plans to donate sperm during the study

          -  Patient has or has a history of any condition, therapy, or lab abnormality that might
             confound the study results, interfere with participation for the full duration of the
             study, or make participation in the study not in the patient's best interest

          -  Patient has donated or received blood within 8 weeks of screening or plans to
             donate/receive blood during and 8 weeks after the study

          -  Patient is experiencing menopausal hot flashes

          -  Patient has chronic heart failure, uncontrolled cardiac arrhythmias, or poorly
             controlled hypertension

          -  Patient has type 1 or 2 diabetes and is poorly-controlled, newly diagnosed, has
             recently had repeated hypoglycemia, or is taking new or recently adjusted antidiabetic
             medication

          -  Patient has uncontrolled metabolic or endocrine disease that influences serum lipids
             or lipoproteins

          -  Patient has kidney disease

          -  Patient had active peptic ulcers within 3 months of screening

          -  Patient has a history of heart attack, stroke, heart bypass surgery, angina, or
             angioplasty within 3 months of screening

          -  Patient is human immunodeficiency virus (HIV) positive

          -  Patient is taking or has taken niacin >50 mg daily within 6 weeks of screening

          -  Patient has had a change to type or dose of LMT regimen within 6 weeks of Visit 1

          -  Patient is taking a statin and a fibrate at screening

          -  Patient is taking a long acting non-steroidal anti-inflammatory drug (NSAID), such as
             naproxen or aspirin >100 mg per day at screening

          -  Patient has arterial bleeding