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

NCT01414166 | Terminated Phase 3 Results

• 2 other identifiers: 0524A-108CTRI/2012/08/002873
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Weeks 12 to 16

Secondary Outcomes (8)

• Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16

  Baseline and Week 16

• Percent Change From Baseline in HDL-C at Week 16

  Baseline and Week 16

• Percent Change From Baseline in Triglycerides (TG) at Week 16

  Baseline and Week 16

• Percent Change From Baseline in Non-HDL-C at Week 16

  Baseline and Week 16

• Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16

  Baseline and Week 16

Study Arms (2)

ERN/LRPT group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

ERN/LRPT DRUG

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

Also known as: Tredaptive™

ERN/LRPT group

placebo DRUG

ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Due to the small number of participants completing the study (n=70), the resulting underpowered nature of any analyses that might be conducted, and the fact that data are not going to be used, no efficacy analyses were performed.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 13, 2015
• Results First Posted: March 14, 2014

Record last verified: 2015-04