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

NCT ID: NCT00961636

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-01-31

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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ERN/LRPT

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

Group Type: EXPERIMENTAL

ER niacin (+) laropiprant (ERN/LRPT)

Intervention Type: DRUG

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

ERN/LRPT then ERN

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.

Group Type: EXPERIMENTAL

ER niacin (+) laropiprant (ERN/LRPT)

Intervention Type: DRUG

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.

Extended-release niacin (ERN)

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo to ERN/LRPT

Intervention Type: DRUG

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

Interventions

ER niacin (+) laropiprant (ERN/LRPT)

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

Intervention Type: DRUG

ER niacin (+) laropiprant (ERN/LRPT)

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.

Intervention Type: DRUG

Extended-release niacin (ERN)

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

Intervention Type: DRUG

Placebo to ERN/LRPT

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 22683042 (View on PubMed)

Other Identifiers

2009_634

Identifier Type: -

Identifier Source: secondary_id

0524A-102

Identifier Type: -

Identifier Source: org_study_id