search
Back to results

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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring (D006937)

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 6, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00150371
Brief Title
Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
Acronym
CANACTFAST
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
(D006937)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
atorvastatin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E 7C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3G 3J9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 2A2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5N 2N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3V9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 3P1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 3P2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 3P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Rothesay
State/Province
New Brunswick
ZIP/Postal Code
E2E 2R2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2K 2T8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax, B3K 5R3
State/Province
Nova Scotia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Y6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 5R3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Downsview
State/Province
Ontario
ZIP/Postal Code
M3M 3E5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Fort Erie
State/Province
Ontario
ZIP/Postal Code
L2A1Z3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hawkesbury
State/Province
Ontario
ZIP/Postal Code
K6A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2C 2N9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Lindsay
State/Province
Ontario
ZIP/Postal Code
K9V 6C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Midland
State/Province
Ontario
ZIP/Postal Code
L4R 4P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Napanee
State/Province
Ontario
ZIP/Postal Code
K7R 2G3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H1
Country
Canada
Facility Name
Pfizer Investigational Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Pfizer Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1C 1S6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saint Catherines
State/Province
Ontario
ZIP/Postal Code
L2N 7H8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. Catherines
State/Province
Ontario
ZIP/Postal Code
L2S 3V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L3T 4X1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7E 4Z3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7E 6E7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1K4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 1L2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montague
State/Province
Prince Edward Island
ZIP/Postal Code
C0A 1R0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Amos
State/Province
Quebec
ZIP/Postal Code
J9T 1T8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Cowansville
State/Province
Quebec
ZIP/Postal Code
J2K 2X9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7N 2k2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 2W3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Le Gardeur
State/Province
Quebec
ZIP/Postal Code
J5Z 3C4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 2W1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4V 2R8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Plessisville
State/Province
Quebec
ZIP/Postal Code
G6L 3J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saint-Eustache
State/Province
Quebec
ZIP/Postal Code
J7P 2V1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Salaberry Du Valleyfield
State/Province
Quebec
ZIP/Postal Code
J6S 4Z5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. Leonard
State/Province
Quebec
ZIP/Postal Code
H1S 3A9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste. Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vaudreuil
State/Province
Quebec
ZIP/Postal Code
J7V 8P9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 3X1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7H 0W6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 7H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7L 2W1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
ZIP/Postal Code
A1E 2E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20151053
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.
Results Reference
derived

Learn more about this trial

Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration

We'll reach out to this number within 24 hrs