A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12 WEEK STUDY, TO EVALUATE THE EFFICACY AND SAFETY OF PROLONGED RELEASE / LAROPIPRANT NIACIN WHEN ADDED TO CURRENT LIPID-MODIFYING THERAPY IN DISLIPIDEMIC PATIENTS.
- Conditions
- -E78 Disorders of lipoprotein metabolism and other lipidaemiasDisorders of lipoprotein metabolism and other lipidaemiasE78
- Registration Number
- PER-046-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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).
• 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 <5 years prior to the signing of the informed consent, except in the case of squamous cell cancer of the skin or basal cells or cancer of the cervix in situ.
• The patient is waiting to donate eggs during the study period, including 14 days of follow-up.
• The patient has a current history or evidence of a condition, therapy or laboratory abnormality that could confuse the results of the study, interfere with the patient´s participation during the duration of the study, or that their participation is not the most convenient for the patient.
• The patient is unlikely to adhere to study procedures, keep appointments or plan to move during the study period.
• The patient is currently participating or has participated in a study with an investigational drug (non-lipid modifier) within 30 days of Visit 1, a lipid modifying compound (investigational or marketed, including statins), within 6 weeks of Visit 1 (fibrate within 8 weeks).
• The patient has donated and / or received blood as follows: has donated blood products or has had phlebotomy> 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 <75% during the transition with placebo AND, in the opinion of the investigator, is not considered capable of maintaining at least 75% compliance with the administration of the dose during the period of active treatment.
• The patient suffers from chronic heart failure defined in Classes III or IV by the New York Heart Association (NYHA), uncontrolled cardiac arrhythmias or unstable hypertension (systolic blood pressure> 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Fasting blood samples will be obtained (at least 12 hours after the last meal / food / drink intake, with the exception of water).<br>Measure:Percentage change with respect to baseline in LDL-C after 12 weeks of active treatment.<br>Timepoints:12 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Fasting blood samples will be obtained (at least 12 hours after the last meal / food / drink intake, with the exception of water).<br>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)<br>Timepoints:12 weeks<br>;<br>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)<br>Measure:Proportion of patients achieving triple lipid control<br>Timepoints:12 weeks<br>