Mixed dyslipidemia (Frederickson Types IIa and IIb) Classification code 10058108
Conditions
Interventions
Product Name: Torcetrapib/Lipitor
Product Code: CP-529,414/ Atorvastatin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade
Sponsors
Pfizer AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must meet the following lipid eligibility criteria based on fasting samples drawn at Q2 and Q3 following TLC and wash-out of all lipid-regulating drugs (for information on calculating CHD risk see Appendix D):· Fasting mean LDL-C:· ³160 mg/dL (4.1 mmol/L) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are excluded if they have any of the following: 1. Pregnancy or a plan to become pregnant or breastfeed during the study or for 30 days afterwards. Unless, for woman of childbearing potential use of contraception for the duration of the study and for 30 days following the last dose of study medication. 2. CHD or CHD risk equivalent, including carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm, diabetes mellitus, pathologic Q waves on ECG, or persistent fasting glucose ³126 mg/dL. 3. Requirement for intermittent systemic corticosteroids at pharmacologic doses (intravenous, oral, or injectable, including joint injections). (see protocol for more details). 4. Primary hypothyroidism with thyroid stimulating hormone (TSH) >2 ´ Upper Limit of Normal (ULN). 5. Active liver disease; or AST (SGOT) or ALT (SGPT) >2.0 ´ ULN, alkaline phosphatase (ALK-P) >1.5 ´ ULN (with elevated liver isoform of alkaline phosphatase), or total bilirubin >1.5 ´ ULN at screening. 6. Intolerance to atorvastatin therapy. 7. Chronic systemic use of any medications known to be associated with an increased risk of myopathy in combination with HMG-CoA reductase inhibitors, or systemic use of any potent inhibitors of cytochrome P450 3A4 (CYP3A4). 8. Uncontrolled hypertension defined as average systolic blood pressure (SBP) >140 mm Hg or average diastolic blood pressure (DBP) >90 mm Hg at either Visit Q3 OR T4. 9. Unexplained serum creatine kinase (CK) >3 ´ ULN at screening (eg, not due to recent trauma, intramuscular injections, or heavy exercise). Subjects with a reason for CK elevation may continue in screening and should have the measurement repeated prior to randomization; a repeat CK >3 ´ ULN is exclusionary. 10. Current moderate or severe congestive heart failure (New York Heart Association [NYHA] Class III or IV. 11. Current significant renal dysfunction including serum creatinine >1.7 ´ ULN or nephrotic syndrome. Subjects with significant proteinuria on urine dipstick should have evaluation to rule out nephrotic syndrome prior to randomization. 12. Any prior history of malignancy (For exceptions, see protocol more details). 13. Gastrointestinal conditions that may limit drug absorption, such as chronic diarrhea, inflammatory bowel disease, partial ileal bypass, gastric stapling, or gastric banding. 14. Current alcohol and/or any other drug abuse or dependence. 15. Uncontrolled depression or psychosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the LDL C lowering and HDL C elevating efficacy of torcetrapib 60 mg administered in a fixed combination with atorvastatin 10 to 80 mg/day compared to atorvastatin alone or placebo in subjects with mixed dyslipidemia (Frederickson Types IIa and IIb). The LDL-C lowering and HDL-C elevating efficacy of the fixed combination will be tested within and across the 2 types of dyslipidemia to establish its incremental benefit over atorvastatin alone, both across and at each of 4 approved atorvastatin dose levels, and over placebo.;Secondary Objective: The secondary objective is to evaluate the modulation of other lipids, apolipoproteins, glucose, and other CHD risk markers by torcetrapib 60 mg administered in a fixed combination with atorvastatin 10 to 80 mg/day compared to that by atorvastatin alone or placebo within and across the 2 types of dyslipidemia.Additional objectives are to characterize the safety and tolerability of torcetrapib/atorvastatin and the population pharmacokinetics of torcetrapib.;Primary end point(s): The primary endpoints are the changes in HDL-C and LDL-C from baseline to follow-up expressed as a percentage of the baseline value (percent change). | — |
Countries
Sweden
Outcome results
None listed