NCT00150371

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

84 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

First QC Date

September 6, 2005

Last Update Submit

February 17, 2021

Conditions

Keywords

(D006937)

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Interventions

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (84)

Pfizer Investigational Site

Calgary, Alberta, T2E 7C5, Canada

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Pfizer Investigational Site

Calgary, Alberta, T3E 0C5, Canada

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Pfizer Investigational Site

Calgary, Alberta, T3G 3J9, Canada

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Pfizer Investigational Site

Edmonton, Alberta, T5A 4L8, Canada

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Pfizer Investigational Site

Edmonton, Alberta, T5K 2A2, Canada

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Pfizer Investigational Site

Edmonton, Alberta, T5N 2N8, Canada

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Pfizer Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

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Pfizer Investigational Site

Coquitlam, British Columbia, V3K 3V9, Canada

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Pfizer Investigational Site

Kelowna, British Columbia, V1Y 2H4, Canada

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Pfizer Investigational Site

Langley, British Columbia, V3A 4H9, Canada

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Pfizer Investigational Site

Surrey, British Columbia, V3R 3P1, Canada

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Pfizer Investigational Site

Vancouver, British Columbia, V5Z 3J5, Canada

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Pfizer Investigational Site

Victoria, British Columbia, V8T 3P2, Canada

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Pfizer Investigational Site

Winnipeg, Manitoba, R2V 3P4, Canada

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Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

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Pfizer Investigational Site

Moncton, New Brunswick, E1G 1A7, Canada

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Pfizer Investigational Site

Rothesay, New Brunswick, E2E 2R2, Canada

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Pfizer Investigational Site

Saint John, New Brunswick, E2K 2T8, Canada

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Pfizer Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

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Pfizer Investigational Site

Halifax, Nova Scotia, B3H 1Y6, Canada

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Pfizer Investigational Site

Halifax, Nova Scotia, B3K 5R3, Canada

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Pfizer Investigational Site

Halifax, B3K 5R3, Nova Scotia, Canada

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Pfizer Investigational Site

Brampton, Ontario, L6T 3J1, Canada

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Pfizer Investigational Site

Burlington, Ontario, L7M 4Y1, Canada

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Pfizer Investigational Site

Courtice, Ontario, L1E 3C3, Canada

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Pfizer Investigational Site

Downsview, Ontario, M3M 3E5, Canada

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Pfizer Investigational Site

Fort Erie, Ontario, L2A1Z3, Canada

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Pfizer Investigational Site

Hamilton, Ontario, L8M 1K7, Canada

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Pfizer Investigational Site

Hawkesbury, Ontario, K6A 1A1, Canada

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Pfizer Investigational Site

Kitchener, Ontario, N2C 2N9, Canada

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Pfizer Investigational Site

Lindsay, Ontario, K9V 6C5, Canada

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Pfizer Investigational Site

Markham, Ontario, L6B 1A1, Canada

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Pfizer Investigational Site

Midland, Ontario, L4R 4P4, Canada

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Pfizer Investigational Site

Napanee, Ontario, K7R 2G3, Canada

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Pfizer Investigational Site

Newmarket, Ontario, L3Y 5G8, Canada

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Pfizer Investigational Site

Niagara Falls, Ontario, L2E 7H1, Canada

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Pfizer Investigational Site

North Bay, Ontario, P1B 2H3, Canada

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Pfizer Investigational Site

North York, Ontario, M3J 1N2, Canada

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Pfizer Investigational Site

Oshawa, Ontario, L1H 1B9, Canada

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Pfizer Investigational Site

Oshawa, Ontario, L1J 2K9, Canada

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Pfizer Investigational Site

Ottawa, Ontario, K1C 1S6, Canada

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Pfizer Investigational Site

Saint Catherines, Ontario, L2N 7H8, Canada

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Pfizer Investigational Site

Saint Catherines, Ontario, L2S 3V7, Canada

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Pfizer Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

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Pfizer Investigational Site

Thornhill, Ontario, L3T 4X1, Canada

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Pfizer Investigational Site

Thunder Bay, Ontario, P7E 4Z3, Canada

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Pfizer Investigational Site

Thunder Bay, Ontario, P7E 6E7, Canada

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Pfizer Investigational Site

Toronto, Ontario, M5C 2T2, Canada

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Pfizer Investigational Site

Toronto, Ontario, M5G 2C4, Canada

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Pfizer Investigational Site

Toronto, Ontario, M8V 3X8, Canada

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Pfizer Investigational Site

Toronto, Ontario, M9W 4L6, Canada

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Pfizer Investigational Site

Windsor, Ontario, N8X 1K4, Canada

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Pfizer Investigational Site

Charlottetown, Prince Edward Island, C1A 1L2, Canada

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Pfizer Investigational Site

Montague, Prince Edward Island, C0A 1R0, Canada

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Pfizer Investigational Site

Amos, Quebec, J9T 1T8, Canada

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Pfizer Investigational Site

Chicoutimi, Quebec, G7H 5H6, Canada

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Pfizer Investigational Site

Cowansville, Quebec, J2K 2X9, Canada

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Pfizer Investigational Site

Greenfield Park, Quebec, J4V 2G8, Canada

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Pfizer Investigational Site

Greenfield Park, Quebec, J4V 2H1, Canada

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Pfizer Investigational Site

Greenfield Park, Quebec, J4V2H1, Canada

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Pfizer Investigational Site

Laval, Quebec, H7N 2k2, Canada

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Pfizer Investigational Site

Laval, Quebec, H7T 2P5, Canada

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Pfizer Investigational Site

Laval, Quebec, H7V 2W3, Canada

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Pfizer Investigational Site

Le Gardeur, Quebec, J5Z 3C4, Canada

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Pfizer Investigational Site

Montreal, Quebec, H3A 1A1, Canada

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Pfizer Investigational Site

Montreal, Quebec, H3S 2W1, Canada

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Pfizer Investigational Site

Montreal, Quebec, H4N 2W2, Canada

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Pfizer Investigational Site

Montreal, Quebec, H4V 2R8, Canada

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Pfizer Investigational Site

Plessisville, Quebec, G6L 3J1, Canada

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Pfizer Investigational Site

Québec, Quebec, G1S 2L6, Canada

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Pfizer Investigational Site

Saint-Eustache, Quebec, J7P 2V1, Canada

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Pfizer Investigational Site

Saint-Léonard, Quebec, H1S 3A9, Canada

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Pfizer Investigational Site

Salaberry Du Valleyfield, Quebec, J6S 4Z5, Canada

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Pfizer Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

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Pfizer Investigational Site

Ste. Foy, Quebec, G1V 4G2, Canada

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Pfizer Investigational Site

Vaudreuil, Quebec, J7V 8P9, Canada

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Pfizer Investigational Site

Regina, Saskatchewan, S4P 3X1, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, S7H 0W6, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 0H6, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 1N8, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 7H9, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, S7L 2W1, Canada

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Pfizer Investigational Site

St. John's, A1E 2C2, Canada

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Pfizer Investigational Site

St. John's, A1E 2E2, Canada

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Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2004

Study Completion

May 1, 2005

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations