Clinical trial NCT00150371: Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: (D006937)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion (%) of subjects achieving their LDL-C target after 12 weeks of treatment according to their 10-year CHD risk category (based on the new canadian guidelines on the management and treatment of dyslipidemia).
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Rothesay
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Saint John
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Halifax, B3K 5R3
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Courtice
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Downsview
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Fort Erie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Lindsay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Midland
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Napanee
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North York
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Saint Catherines
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: St. Catherines
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Montague
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Amos
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Cowansville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Le Gardeur
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Plessisville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saint-Eustache
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Salaberry Du Valleyfield
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St. Leonard
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste. Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Vaudreuil
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: St. John's
country: Canada
facility: Pfizer Investigational Site
city: St. John's
country: Canada
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ur E, Langer A, Rabkin SW, Calciu CD, Leiter LA; CanACTFAST Study Investigators. Achieving cholesterol targets by individualizing starting doses of statin according to baseline low-density lipoprotein cholesterol and coronary artery disease risk category: the CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) study. Can J Cardiol. 2010 Feb;26(2):80-6. doi: 10.1016/s0828-282x(10)70003-9.