Clinical trial NCT00961636: A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period
timeFrame: Week 21 to Week 32
Secondary outcomes:
measure: Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period
timeFrame: Week 21 to Week 32
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Maccubbin DL, Chen F, Anderson JW, Sirah W, McCrary Sisk C, Kher U, Olsson AG, Bays HE, Mitchel YB. Effectiveness and safety of laropiprant on niacin-induced flushing. Am J Cardiol. 2012 Sep 15;110(6):817-22. doi: 10.1016/j.amjcard.2012.05.009. Epub 2012 Jun 8.