A WORLD, MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED WITH PLACEBO STUDY, OF 76 WEEKS TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ANACETRAPIB TO BE ADDED TO THE CURRENT THERAPY WITH A STATINARY IN PATIENT COURTES (CORDERMANITY IN CHD) WITH EQUIVALENT RISK OF CHD

Not Applicable

• Conditions: -E78 Disorders of lipoprotein metabolism and other lipidaemias; Disorders of lipoprotein metabolism and other lipidaemias; E78

• Registration Number: PER-127-08
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient is a man or a woman who is> 18 and <80 years old on the day of the signing of the informed consent.
• Based on the NCEP ATP III guidelines, the patient has CHD / disease with an equivalent risk of CHD (including diabetes) and LDL-C <100 mg / dL (2.59 mmol / L).
• The patient is treated with a statin ± another lipid modifying therapy and has HDL-C <60 mg / dL (1.55 mmol / L).
• The patient has triglyceride concentrations (TG) <400 mg / dL (4.52 mmol / L).
• A patient who is potentially fertile agrees to remain in abstinence * 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, condom, vasectomy and hormonal contraceptive.
• The patient has a study drug compliance greater than 75% during the transition phase with single blind placebo (as determined by pill count) or, according to the opinion of the researcher, compliance will improve after counseling additional.

Exclusion Criteria

• The patient has severe chronic heart failure defined by Classes III or IV established by the New York Heart Association (NYHA).
• The patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke, MI within 3 months prior to Visit I.
• LDL-C <50 mg / dL (1.29 mmoI / L).
• The patient has uncontrolled hypertension
• The patient has exclusive laboratory values ​​as listed below: CPK (creatine phosphokinase)> 2 x upper limit of normal (ULN) [according to the central laboratory reference ranges]. ALT (alanine aminotransferase), or AST (aspartate aminotransferase)> 2 x upper limit of normal (ULN) [according to the reference ranges of the central laboratory].
• The patient has recently diagnosed Type 1 or Type 2 diabetes (within 3 months of Visit 1) or poorly controlled (HbAlc> 8.5%). Note: Patients who are currently receiving antidiabetic drug (s) should be in 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 lower limit of the normal central laboratory or> 20% above the reference range of the upper limit of normal. Note: In the case of patients receiving a thyroid hormone, there is no lower threshold of TSH for admission and the patient must be at a stable dose for> 6 weeks before the randomization visit. Note: A review will be carried out if the original value of the TSH 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.
• The patient has an eGFR <30 mL / min / 1.73m2 based on an equation of 4 variables of MDRD (Diet Modification in Nephropathy), nephrotic syndrome, or other clinically significant nephropathy.
• The patient has a history of mental instability, drug / alcohol abuse within the last 5 years or major psychiatric disease not adequately controlled and unstable.
• The patient has a history or current 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 the most convenient for 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 regimen that exceeds the daily exercises currently recommended by the American Cardiology Association / American Diabetes Association (for example, marathon training, bodybuilding training, intensive training for military reserves, etc. ).
• The patient has a history of malignancy <5 years before the signing of informed consent, except for basal cell or squamous cell cancer or cervical cancer in situ properly treated.
• The patient has donated blood products or has had phlebotomy> 300 mL within 8 weeks of signing the informed consent, or intends to donate 250 mL of blood products or receive blood products within the projected durat

Study & Design

• Study Type: Interventional
• Study Design: Not specified