None listed
Conditions
Interventions
They will receive placebo orally for 12 weeks
Group 1 Type of group
For 4 weeks (From Visit 3 to Visit 4) Niacin for Prolonged Release (ER) 1g / Laropiprant 20 mg.
For 8 weeks (From Visit 4 to Visit 5) Niacin for Prolonged Release (ER) 2g / Laropiprant 40 mg
Group name:Group 2 Type of group
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female> 18 years of age completed until the day of signing the informed consent. • The patient understands the study procedures, available alternative treatments and the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. • Contraception for women patients who are potentially fertile: a woman patient who is potentially fertile agrees to abstain from sexual intercourse or use (or commit to her partner´s use) if 2 acceptable methods of birth control are required locally for the duration of the study. An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. • The patient has been receiving a stable dose of an LMT specified in the protocol (simvastatin, atorvastatin, or rosuvastatin alone or combined / co-administered with ezetimibe) for 6 weeks prior to Visit I and agrees to continue with the same LMT and dose for the duration of the study. • The patient has TG levels <500 mg / dL (<5.65 mmol / L).
Exclusion criteria
Exclusion criteria: • The patient is pregnant, is breastfeeding, or is expecting to conceive during the study period, including 14 days of post-study follow-up. • The patient has a history of malignancy 300 mL within 8 weeks prior to signing the informed consent, intends to donate or receive blood products during the period of study, intends to donate more than 250 mL of blood products within 8 weeks after the last study visit. • The patient at the time of signing the informed consent uses recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse. • Patient compliance was 160 mm Hg or diastolic blood pressure> 100 mm Hg). • The patient has type 1 or type 2 diabetes mellitus • The patient has an uncontrolled endocrine or metabolic disease that is known to influence serum lipids or lipoproteins. • The patient has nephrotic syndrome or other clinically significant kidney disease. • The patient has active peptic ulcer within 3 months of Visit I. • The patient has had a gout episode within 1 year of Visit 1, unless the patient is currently taking allopurinol. • The patient has a history of hypersensitivity or allergic reaction to niacin or products containing niacin. • The patient has a history of myocardial infarction, cerebral infarction, coronary artery bypass surgery or other revascularization procedures, unstable angina or angioplasty within 3 months of Visit 1. • The patient has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption. • The patient has chronic hepatobiliary or hepatic disease. • The patient is HIV positive. • The patient is currently taking or has taken billiard acid sequestrants, niacin> 250 mg, red rice yeast products (eg, Cholestin), omega-3 fatty acid esters by prescription (eg, Lovaza), or statins excluded (lovastatin, pravastatin, fluvastatin) within 6 weeks of Visit 1, or fibrates within 8 w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting blood samples will be obtained (at least 12 hours after the last meal / food / drink intake, with the exception of water). Measure:Percentage change with respect to baseline in LDL-C after 12 weeks of active treatment. Timepoints:12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting blood samples will be obtained (at least 12 hours after the last meal / food / drink intake, with the exception of water). Measure:Percentage change with respect to baseline in LDL-C / HDL-C, HDL-C, TG, non-HDL-C, Apo B, Apo A-I, TC / HDL-C ratio, TC, Lp (a) Timepoints:12 weeks ; Outcome name:The percentage of patients who achieve triple control in week 12 will be analyzed through a logistic regression model with treatment, LMT and sex as covariates. Fasting blood samples will be obtained (at least 12 hours after the last meal / food / drink intake, except for water) Measure:Proportion of patients achieving triple lipid control Timepoints:12 weeks | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed