Dyslipidemia Clinical Trial
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
Verified date | April 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Drugs Controller General of India |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 244 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
Secondary | 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. | Baseline and Week 16 | No |
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