None listed
Conditions
Interventions
Group A Type of group
In addition to receiving SCH 58235 10 mg double-blind, patients will continue to receive atorvastatin 10 mg openly during the entire study. Additional atorvastatin (10 mg), with blindness, will be added in patients who do not achieve the LDL-C goal (
In addition to receiving 10 mg double-blind atorvastatin, patients will continue to receive atorvastatin 10 mg openly throughout the study. Atorvastatin (20 mg) will be added blindly to the regimen of patients who do not reach the LDL-C target (
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The variable of primary efficacy is the percentage of subjects who achieve the goal of LDL-G after 14 weeks of treatment, measured directly by radicularisation. The analysis will be done using the chi-square technique. A confidence interval of ninety-five percent is foreseen for the primary efficacy parameter. Summary statistics will be provided for the primary efficacy variable in the following subgroups: sex, age ( 65) and race (Caucasian and non-Caucasian). In addition to the final point, analysis will also be foreseen for the primary efficacy variable in each of the moments. Descriptive statistics (mean, standard deviation) will be provided for the secondary variables: - LDL-Cholesterol (Friedewaids calculation) - Total cholesterol - Triglichide - HDL-Cholesterol (and HDL2 and HDL3 subfractions) - Apolipoprotein Ai - Apolipoprotein B - Lipoprotein (a) Measure:Efficacy Timepoints:After the 14 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:El numero de sujetos que registraron eventos adversos y la incidencia de eventos adversos especificos se tabularan. Se detallaran los datos de laboratorio, señalando los valores que se encuentren fuera de los rangos normales. Measure:Safety Timepoints:During treatment ; Outcome name:The quality of life measured by the SF-36 Questionnaire and the Specific Questionnaire for the Patient are considered an exploratory analysis and the results will be summarized by treatment groups. Measure:Life Quality Timepoints:During treatment | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed