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Niacin/Laropiprant Tablet for South and Southeast Asians With Low HDL at Risk for Cardiovascular Disease (MK-0524A-108 AM1)

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
ClinicalTrials.gov Identifier:
NCT01414166
First received: August 9, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  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
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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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 or placebo 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 ERN/LRPT or 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
ClinicalTrials.gov Identifier: NCT01414166     History of Changes
Other Study ID Numbers: 0524A-108
Study First Received: August 9, 2011
Last Updated: March 21, 2013
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 May 23, 2013