Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration (CANACTFAST)

Viatris

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Treatments

Drug: atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150371

A2581091

Details and patient eligibility

About

The objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required

Sex

All

Ages

30 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 30 to 79 years old
Triglyceride level 6.8 mmol/L at screening
LDL-C of 5.7 mmol/L at screening

Exclusion criteria

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)