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OPEN STUDY ON THE SAFETY AND LONG-TERM TOLERABILITY OF SCH 58235 PLUS ATORVASTATIN IN SUBJECTS WITH CORONARY CARDIOPATHY OR MULTIPLE RISK FACTORS WITH PRIMARY HYPERCHOLESTEROLEMIA NOT CONTROLLED BY AN INITIAL DOSAGE OF ATORVASTATIN (10 MG)

OPEN STUDY ON THE SAFETY AND LONG-TERM TOLERABILITY OF SCH 58235 PLUS ATORVASTATIN IN SUBJECTS WITH CORONARY CARDIOPATHY OR MULTIPLE RISK FACTORS WITH PRIMARY HYPERCHOLESTEROLEMIA NOT CONTROLLED BY AN INITIAL DOSAGE OF ATORVASTATIN (10 MG)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-045-00
Enrollment
13
Registered
2000-01-01
Start date
2000-12-26
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
SCH 58235 10 mg + atorvastatin 10 mg daily for 12 months will be administered

Sponsors

SCHERING PLOUGH RESEARCH INSTITUTE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Subjects who have successfully completed the 14-week double-blind study on the efficacy and safety of SCH 58235 with atorvastatin in subjects with coronary heart disease or multiple risk factors (Protocol P00693). The entry to this protocol must occur at the time of completing Protocol P00693. • All women must have a negative pregnancy test before entering the study. Those who are of childbearing age must agree to use an effective barrier contraceptive method throughout the study, as well as 30 days after the last dose of atorvastatin. • Postmenopausal women receiving postmenopausal hormone therapy or raloxifene should maintain a stable estrogen regimen (ERT), estrogen / progestin (HRT) or raloxifene during the study period. • Subjects must be willing to comply with the NCEP Step I diet or a more strict diet during the study. • Subjects must be willing to participate in the study and complete all evaluations. • Subjects must agree to provide informed consent in writing.

Exclusion criteria

Exclusion criteria: • Patients who have been withdrawn from Protocol P00693 due to adverse effects or unsatisfactory compliance. • People who are in a situation or have any condition that, at the discretion of the Investigator, could interfere with their optimal participation in the study. • Women who are pregnant or breastfeeding. • Subjects known to be HIV positive.

Design outcomes

Primary

MeasureTime frame
Outcome name:The security panel includes • Hematology, which includes differential counting, white blood cell (WBC) count, platelet count, hemoglobin, and hematocrit • Blood chemistries (fasting): total protein, albumin, calcium, inorganic phosphorus, fasting glucose, blood urea nitrogen (BUN), uric acid, total bilirubin, alkaline phosphatase, serum glutamic-pyruvic transaminase / alanine-aminotransferase (SGPT) / ALT), serum glutamic-oxaloacetic transaminase / aspartate-aminotransferase (SGOT / AST), serum creatinine, serum electrolytes (Na, K, Cl) phosphocreatine kinase (CPK), gamma-glutamyl transpeptidase (GGT) Measure:Safety Timepoints:The security panel will be determined in Visits 1, 3, 4 and 6.—

Secondary

MeasureTime frame
Outcome name:Lipid panel (Total Cholesterol, HDL-C and TG.) LDL-C will be calculated using the Friedewald equation (LDL = TG- [TG / 5] -HDL). Measure:Target levels of LDL-C Timepoints:On visits 1, 2, 5, and 6—

Countries

Peru

Contacts

Public ContactJorge Timoteo

SCHERING PLOUGH DEL PERU S.A.

jorge.timoteo@spcorp.com710-3653

Outcome results

None listed

Source: REPEC (via WHO ICTRP)