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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Dyslipidemia

Treatments

Drug: Extended-release niacin (ERN)

Drug: Placebo to ERN/LRPT

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00961636

0524A-102

2009_634

Details and patient eligibility

About

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.

Enrollment

1,152 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,152 participants in 3 patient groups, including a placebo group

ERN/LRPT

Experimental group

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

Treatment:

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

ERN/LRPT then ERN

Experimental group

Description:

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 then Two 1g tablets ERN (2g total) once daily for 12 weeks.

Treatment:

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

Drug: Extended-release niacin (ERN)

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

Placebo

Placebo Comparator group

Description:

One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.

Treatment:

Drug: Placebo to ERN/LRPT