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: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: ERN/LRPT
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 244
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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™
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.
Drug: placebo
ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01414166     History of Changes
Other Study ID Numbers: 0524A-108, CTRI/2012/08/002873
Study First Received: August 9, 2011
Results First Received: November 21, 2013
Last Updated: January 30, 2014
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014