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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014