Back to resultsNiacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Primary Purpose
Dyslipidemia
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ERN/LRPT
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ERN/LRPT group
Placebo group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
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
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
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
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
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
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
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
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
The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01414166
Brief Title
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
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
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERN/LRPT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
ERN/LRPT
Other Intervention Name(s)
Tredaptive™
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
Description
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
Time Frame
Baseline and Weeks 12 to 16
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16
Description
The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in HDL-C at Week 16
Description
The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Triglycerides (TG) at Week 16
Description
The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Non-HDL-C at Week 16
Description
The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16
Description
The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16
Description
The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
Description
The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16
Description
The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
Time Frame
Baseline and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
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