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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00961636
First received: August 17, 2009
Last updated: January 14, 2012
Last verified: January 2012
History of Changes

August 17, 2009
January 14, 2012
October 2009
January 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Number of Days Per Week with Global Flushing Severity Score (GFSS) >= 4 Over the 12-week post-withdrawal period (Weeks 21 to 32) [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00961636 on ClinicalTrials.gov Archive Site
Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period [ Time Frame: Week 21 to Week 32 ] [ Designated as safety issue: No ]
Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.
Percentage of Patients with Maximum GFSS >= 4 During the 12-week post-withdrawal period (Weeks 21 to 32) [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102 AM1)(COMPLETED)
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dyslipidemia
  • Drug: 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
  • 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.
  • Drug: Extended-release niacin (ERN)
    Two 1g tablets ERN (2g total) once daily for 12 weeks.
  • 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
  • Experimental: 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: Drug: ER niacin (+) laropiprant (ERN/LRPT)
  • Experimental: 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.
    Interventions:
    • Drug: ER niacin (+) laropiprant (ERN/LRPT)
    • Drug: Extended-release niacin (ERN)
  • Placebo Comparator: Placebo
    One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
    Intervention: Drug: Placebo to ERN/LRPT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1152
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00961636
MK-0524A-102, 2009_634
No
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP