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

NCT00961636 | Completed Phase 3 Results

• 2 other identifiers: 0524A-1022009_634
• Study Type: interventional
• Target: 1,152
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period

  Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7\*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, \>0 to 0.5, \>0.5 to 1, \>1 to 2, \>2 to 3, and \>3 days per week.

  Week 21 to Week 32

Secondary Outcomes (1)

• Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period

  Week 21 to Week 32

Study Arms (3)

ERN/LRPT

EXPERIMENTAL

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

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

ERN/LRPT then ERN

EXPERIMENTAL

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.

Drug: ER niacin (+) laropiprant (ERN/LRPT); Drug: Extended-release niacin (ERN)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to ERN/LRPT

Interventions

ER niacin (+) laropiprant (ERN/LRPT) 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

Extended-release niacin (ERN) DRUG

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

ERN/LRPT then ERN

Placebo to ERN/LRPT DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22683042 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

MK-0524

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 19, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 16, 2015
• Results First Posted: February 17, 2012

Record last verified: 2015-01