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Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)

This study has been terminated.
(In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01414166
First received: August 9, 2011
Last updated: July 29, 2014
Last verified: July 2014

August 9, 2011
July 29, 2014
September 2011
February 2013   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16 [ Time Frame: Baseline and Weeks 12 to 16 ] [ Designated as safety issue: No ]
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
Change from baseline in LDL-C averaged across Week 12 and Week 16 [ Time Frame: Baseline and Weeks 12 to 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01414166 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.
  • Percent Change From Baseline in HDL-C at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.
  • Percent Change From Baseline in Triglycerides (TG) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.
  • Percent Change From Baseline in Non-HDL-C at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.
  • Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.
  • Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.
  • Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.
  • Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
  • Change from baseline in ratio of LDL-C to HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in TG [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in ratio of total cholesterol (TC) to HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in lipoprotein(a) (Lp[a]) [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein B (Apo B) [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal

The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyslipidemia
  • Drug: ERN/LRPT
    ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
    Other Name: Tredaptive™
  • Drug: placebo
    ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
  • Experimental: ERN/LRPT group
    All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks.
    Intervention: Drug: ERN/LRPT
  • Placebo Comparator: Placebo group
    All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
244
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • LMT ineligible
  • Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
  • HDL-C <40 mg/dL (1.03 mmol/L) in males and <50 mg/dL (1.29 mmol/L) in females
  • Triglyceride (TG) level <300 mg/dL (3.39 mmol/L).
  • Fasting serum glucose (FSG) at Visit 1 AND Visit 2 <126 mg/dL (<7 mmol/L)
  • Hemoglobin A1c (HbA1c) level <6.5%
  • Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period

Exclusion criteria:

  • History of malignancy ≤5 years prior to signing informed consent, except for adequately-treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
  • Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
  • Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
  • Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study
  • Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%
  • Risk factors for coronary heart disease
  • Active or chronic hepatobiliary or hepatic disease
  • Active peptic ulcer disease within 3 months of Visit 1
  • History of hypersensitivity or allergic reaction to niacin or niacin-containing products
  • Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol
  • Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin >50 mg as monotherapy or coadministered with other LMTs)
  • Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering
  • Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)
  • Uncontrolled illness or infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01414166
0524A-108, CTRI/2012/08/002873
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

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