STUDY PHASE III DOUBLE BLIND EFFICACY AND SAFETY OF SCH 58235 (10 MG) IN ADDITION TO ATORVASTATIN IN SUBJECTS WITH CORONARY CARDIOPATITIS WITH MULTIPLE FACTORS OF CARDIOVASCULAR RISK AND WITH HYPERCHOLESTEROLEMIA NOT CONTROLLED BY AN INITIAL DOSAGE (10 MG) OF ATORVASTATI

Not Applicable

• Conditions: -E780 Pure hypercholesterolaemia; Pure hypercholesterolaemia; E780

• Registration Number: PER-017-00
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-03-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• Adults (18 years of age or older) of any sex and race.
• Subjects with primary hypercholesterolemia and known coronary heart disease (CHD) or multiple risk factors for CHD (greater than or equal to two) who do not meet the LDL-C goal <100 mg / dl (2.59 mmoi / l), with LDL-plasma cholesterol> 130 mg / dl (3.37 mmol / l) and plasma triglycerides | 350 mg / dl (3.99 mmol / l) while treated with the initial dose (10 mg) of ato-astatine , for at least 4 weeks before the initial determination of lipid fitness (Q1).
• All women must submit a negative pregnancy test before entering the study. Women with a potential to become pregnant should agree to use an effective barrier method of birth control for the duration of the study, as well as one month after completion of the study.
• Postmenopausal women receiving postmenopausal hormone therapy or raloxifene should be maintained on a stable estrogen (ERT), estrogen / progestin (HRT) or raloxifene regimen during e! study period.
• Subjects must be willing to observe the Step 1 diet of the NCEP determined by a RISCO score of no more than 24 during the entire study. The ability to complete the Journals of the
• Diet.
• Subjects must be willing to participate in the study and to comply with all follow-up evaluations.
• Subjects must agree to give written informed consent.

Exclusion Criteria

• General
• Persons with a history of mental instability, drug / alcohol abuse within the previous five years or persons who have been treated or who are being treated for severe psychiatric illnesses, which in the opinion of the Investigator could interfere with optimal participation in the study.
• People who are in a situation or have any condition, which in the opinion of the Investigator, could interfere with an optimal participation in the study.
• Underlying disease that probably limits the duration of life to less than 1 year.
• Subjects that have been previously randomized in any of the studies in which SCH 58235 was evaluated.
• Subjects with known hypersensitivity or any contraindication to atorvastatin.
• Pregnant or breastfeeding women.
• Concomitant diseases
• NYHA Congestive Heart Failure Class III or IV.
• Uncontrolled cardiac arrhythmias.
• myocardial infarction, coronary bypass or angioplasty within 3 months prior to admission to the study.
• Unstable or severe peripheral arterial disease within three months before admission to the study.
• Angina pectoris unstable.
• Disorders of the haematological, digestive or central nervous systems, including cerebrovascular disease or degenerative disease that would limit the evaluation or participation in the study.
• Diabetes mellitus not controlled (determined by HbAic) or newly diagnosed (within the month prior to admission to the study).
• Uncontrolled endocrine or metabolic disease, which is known to influence serum lipids or lipoproteins. Clinically euthyroid subjects treated with replacement doses of thyroid hormone are considered suitable for incorporation.
• Known impairment of renal function (creatinine> 2.0 mg / day), dysproteinemia, nephrotic syndrome or other kidney disease (urinary protein 24 hours 3+ or 1 gram).
• Active or chronic hepatobiliary or hepatic disease (subjects with AST or ALT> 2 times the upper limit of the reference range of the laboratory will be excluded).
• Subjects known to be HIV positive.
• Subjects with known coagulopathy (PT or PTT at Visit 2> 1.25 times the control).
• Concomitant (Prohibited) Medications
• Agents that alter lipids, other than atorvastatin administered according to protocol, for the duration of the study.
• Oral corticosteroids.
• Cardiovascular drugs such as beta-blockers, calcium channel blockers, GAS inhibitors, nitrates or a-adrenergic blockers or thiazide diuretics will be allowed, provided that the dose remains constant throughout the duration of the study and that the subject has received a stable dose during the eight weeks prior to obtaining the initial level of fitness for LDL-C (Q1). Acetylsalicylic acid (eg aspirin) is allowed up to 325 mg / day administered in order to inhibit platelet aggregation.
• Treatment with psyllium or other fiber-based laxatives a / less than a stable regimen for at least four weeks prior to the initial determination of lipid fitness. The dose should be kept constant during the study period.
• Treatment with troglitazone (Rezulin®) unless it is a stable regimen for at least six weeks before the initial determination of lipid fitness. The dose should be kept constant during the study period.
• Treatment with orlistat.
• Treatment with cyclosporine.
• Use of any investigational drug within 30 days before admission to the study.
• Treatment with known interaction agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified