Clinical Trial: Canactfast: Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
This study has been completed.
|Hypercholesterolemia (D006937) || Drug: atorvastatin ||Phase IV |
MedlinePlus related topics: Cholesterol
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, 12 Week Treatment Single Step Titration Open-Label Study Assessing The % Of Patients Achieving Ldl-C Target With Atorvastatin Starting Doses Of 10mg, 20mg, 40mg and 80mg.
Secondary Outcomes: The global proportion (%) of patients reaching targets when risk categories are combined The proportion (%) of subjects achieving BOTH their LDL-C and TC/HDL-C ratio targets after 6 and 12 weeks of treatment, globally and according to their 10-year
Expected Total Enrollment: 1100
Study start: June 2004
- Age 30 to 79 years old
- Triglyceride level ï£ 6.8 mmol/L at screening
- LDL-C of ï£ 5.7 mmol/L at screening
- Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. The latter are defined as: abstinence, surgical sterilization, oral contraceptives for at least 3 cycles, intrauterine device, implant, depot injection, or barrier method in conjunction with contraceptive foam or jelly.
- Subjects whose blood cholesterol levels are controlled (LDL-C targets) with statins other than atorvastatin
- Subjects receiving statin doses higher than the following: 10-40mg for simvastatin , 20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin. Subjects already treated with atorvastatin at the time of screening are not eligible unless atorvastatin has been discontinued at least 2 months prior to screening
- Subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or fibrates or niacin or fish oils)
Pfizer CT.gov Call Center, Study Director, Pfizer
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150371
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13