Coronary Heart Disease Classification code 10011078
Conditions
Interventions
Product Name: Torcetrapib/Atorvastatin
Product Code: CP-519,414/Atorvastatin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Pha
Sponsors
Pfizer AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with high risk of CVD events defined as any of the following: a. Prior myocardial infarction in which the most recent event occurred 1 month (30 days) to 60 months prior to the screening visit. b. Previous cardiac revascularization procedure prior to screening (see protocol for more details) c. Pre existing atherosclerotic CHD (documented acute coronary syndrome including unstable angina) in which the most recent event occurred 1 month (30 days) to 60 months prior to the screening visit. (see protocol for more details) d. Pre existing symptomatic carotid artery disease (documented prior stroke defined as persistent brain deficit lasting more than 24 hours with a demonstrable lesion by CT or MRI scan) at least one month (30 days) prior to screening. e. Pre existing PVD; documented as either a peripheral intervention [at least one month (30 days) prior to screening] or ankle/brachial index (ABI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, lactating, or who are planning to become pregnant Women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months (eg, hormonal contraception, intrauterine device, barrier method plus spermicide). 2. Subjects at Visit 1 who are not on prior prescription lipid-altering treatment, and have an LDL C of 140 mmHg or an average diastolic blood pressure (DBP) >90 mmHg, at baseline. Subjects with an average SBP >140 mmHg or DBP >90 mmHg at screening or any run in visit (Visits 2 6) should receive appropriate treatment for hypertension. 8. Fasting triglycerides >500 mg/dL (5.6 mmol/L) at Visit 1 or 2. 9. Subjects receiving the following concomitant lipid-altering therapy ( non statins and statins) or therapies affecting LDL-C, HDL-C and TG at Visit 1: 10. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG CoA reductase inhibitors. 11. Subjects with any other medical condition or laboratory abnormality prior to randomization, which in the opinion of the principal investigator could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study, including but not limited to: a. Subjects with uncontrolled diabetes mellitus; b. Subjects with renal disease c. Subjects with uncontrolled hypothyroidism defined as a TSH >2 times the ULRR at Visit 1; d. Subjects with any active hepatobiliary disease (including cirrhosis), serologic evidence of past or active hepatitis B or hepatitis C infection, or an AST or ALT >2 times the ULRR, alkaline phosphatase >1.5 times the ULRR with elevated liver isoform of alkaline phosphatase or total bilirubin >1.5 times the ULRR at Visit 1 or 2; e. Subjects with unexplained serum CK >3 times the ULRR at Visit 1 or 2 (eg, not due to recent trauma, intramuscular injections, heavy exercise). A repeat CK >3 times ULRR in the absence of conditions explaining CK elevation is exclusionary; f. Subjects with any prior history of malignancy. g. Subjects with gastrointestinal disease limiting drug absorption or partial ileal bypass, gastric stapling, or gastric binding; h. Subjects with alcohol and/or any other drug abuse or dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Time to first occurrence of an MCVE defined as:· CHD death,· Nonfatal myocardial infarction (MI), or· Stroke (fatal and nonfatal);Main Objective: The primary objective of this clinical trial is to demonstrate whether or not the fixed combination torcetrapib/atorvastatin, can incrementally reduce the risk for future occurrence of major cardiovascular disease events (MCVE), when compared to atorvastatin alone, in subjects with coronary heart disease (CHD) or risk equivalents.;Secondary Objective: Secondary objectives will include examining the effect of torcetrapib/atorvastatin over that of atorvastatin alone on the following: 1. The time to first occurrence of the following clinical endpoints:· Major CHD events composite (defined as CHD death and nonfatal MI)· MCVE, coronary revascularization procedures, and PVD composite· Stroke (fatal and nonfatal) and (TIA) composite· Major CHD events, stroke (fatal and nonfatal), and TIA composite· All cause mortality 2. Change from baseline in LDL-C and HDL-C | — |
Countries
Spain, Sweden, United Kingdom
Outcome results
None listed