A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF 76 WEEKS OF DURATION TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ANACETRAPIB WHEN ADDED TO THERAPY IN PROGRESS WITH A STATINE IN PATIENTS WITH HYPERCHOLESTEROLEMIA OR MIXED HYPERLIPIDEMIA
- Conditions
- -E78 Disorders of lipoprotein metabolism and other lipidaemiasDisorders of lipoprotein metabolism and other lipidaemiasE78
- Registration Number
- PER-071-08
- 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 a man or woman who is> 18 and <80 years of age on the day of signing the informed consent.
• The patient meets one of the criteria of LDL-C based on the categorization of CHD risk of the NCEP ATP III
• The patient is treated with a statin ± another lipid-modifying therapy and meets the HDL-C criteria.
• The patient has triglyceride (TG) concentrations <400 mg / dL (4.52 mmol / L).
• A patient who is potentially fertile agrees to abstain or use (or have her partner use) 2 acceptable methods of birth control throughout the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy and hormonal contraceptive.
• The patient has a compliance of the study drug greater than 75% during the transition phase with single-blind placebo (as determined by the count of pills) or, according to the opinion of the researcher, compliance will improve after counseling additional.
• The patient has severe chronic heart failure defined by Classes III or IV established by the New York Heart Association (New York Cardiology Association - NYHA).
• The patient has uncontrolled cardiac arrhythmias, MI, PCI, CABO, unstable angina, or stroke, MI within 3 months prior to Visit 1.
• LDL-C <50 mg / dL (1.29 mmol / L).
• The patient has uncontrolled hypertension
• The patient has exclusive laboratory values as listed below: CPK (creatine phosphokinase)> 2 x normal upper limit (ULN) [according to the reference ranges of the central laboratory], ALT (alanine aminotransferase), or AST (aspartate aminotransferase)> 1.5 x normal upper limit (ULN) [according to the reference ranges of the central laboratory].
• The patient has Type 1 or Type 2 diabetes diagnosed recently (within 3 months of Visit 1) or poorly controlled (HbAlc> 8.5%). Note: Patients currently receiving antidiabetic drug (s) should be on a stable dose regimen (except for ± 10 units of insulin) for a minimum of 3 months before Visit 1.
• A patient has hyper or hypothyroidism that is defined by a TSH below the reference range of the normal lower limit of the central laboratory or> 20% above the reference range of the normal upper limit. Note: In the case of patients receiving a thyroid hormone, there is no lower TSH threshold for admission and the patient must be in a stable dose for> 6 weeks before the randomization visit. Note: A review will be allowed if the original TSH value is less than 40% above or below the reference range, but the patient must meet the criteria after the review.
• The patient has homozygous familial hypercholesterolemia, Type I or V hyperlipidemia.
• The patient has an active or chronic hepatobiliary or hepatic disease. Note: Patients with chronic hepatitis B or C or non-alcoholic steatosis may participate in the study if their ALT and AST are within the range specified in the protocol.
• The patient has an eGFR <30 mL / min / l .73m ^ based on an equation of 4 MDRX variables (Modification of the Diet in Nephropathy), nephrotic syndrome, or other clinically significant nephropathy.
• The patient has a history of mental instability, drug addiction / alcoholism within the last 5 years or major psychiatric illness not adequately controlled and unstable.
• The patient has a current history or evidence of any condition, therapy, laboratory abnormality or other circumstance that could confuse the results of the study, or interfere with their participation throughout the study, so that it is not in the best interest of the patient participate in the study.
• The patient is pregnant or breastfeeding, or expects to become pregnant during the study.
• The patient has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption.
• The patient is positive for Human Immunodeficiency Virus (HIV) (as assessed by medical history).
• The patient is currently participating in a vigorous exercise regime that exceeds the daily exercises currently recommended by the American Association of Cardiology / American Diabetes Association (eg, marathon training, bodybuilding training, intensive training for military reserves, etc.). ).
• The patient has a history of malignancy <5 years before the signing of the informed consent, with the exception of basal cell or squamous cell cancer or cervical cancer in situ adequately treated.
• The pati
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Measurement of LDL-C levels by laboratory tests during the study.<br>Measure:Percentage change with respect to the baseline in the LDL-C in Week 24.<br>Timepoints:Week 24.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Measurement of HDL-C, No HDL-C, Apo B and Apo-Al levels by laboratory tests during the study.<br>Measure:Percentage change with respect to baseline in HDL-C, No HDL-C, Apo B and Apo-Al in Week 24 and Week 76<br>Timepoints:Week 24 and Week 76<br>;<br>Outcome name:Measurement of LDL-C levels by laboratory tests during the study.<br>Measure:Percentage change with respect to baseline in LDL-C at 76 weeks<br>Timepoints:76 weeks<br>;<br>Outcome name:The safety and tolerability endpoints such as blood chemistry, hematology, vital signs, and ECG will be monitored. Clinical adverse events, selected safety endpoints of interest, and laboratory values that exceed the predefined limits of the change will be evaluated.<br>Measure:Safety and Tolerability<br>Timepoints:During the study<br>