A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102 AM1)(COMPLETED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00961636
• Date of registration: 17/08/2009
• Primary sponsor: Merck
• Public title: A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102 AM1)(COMPLETED)
• Scientific title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of ERN/LRPT in Patients With Dyslipidemia
• Date of first enrolment: October 2009
• Target sample size: 1152
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00961636
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Guatemala, Israel, Lithuania, Malaysia, New Zealand, Norway, Panama, Peru, Puerto Rico, Spain, Sweden, United States

Contacts

• Name: Medical Monitor
• Affiliation: Merck

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dyslipidemia

Intervention(s)

Drug: ER niacin (+) laropiprant (ERN/LRPT)

Drug: Extended-release niacin (ERN)

Drug: Placebo to ERN/LRPT

Primary Outcome(s)

Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) =4 Partitioned Into 6 Categories During the Postwithdrawal Period [Time Frame: Week 21 to Week 32]

Secondary Outcome(s)

Number of Participants With Maximum GFSS =4 During the Post-withdrawal Period [Time Frame: Week 21 to Week 32]

Secondary ID(s)

2009_634

MK-0524A-102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors