HypercholesterolemiaPhase 3CANACTFASTNCT00150371

Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration

A Phase 3 study testing atorvastatin in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 84 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 30 to 79 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: atorvastatin
How many people: 1,100 participants
Where: 84 sitesCanada
Study dates: Jun 2004to May 2005
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

84 sites in 1 country.

City, postcode or hospital

84 sites in 1 country

Canada84 sites

Pfizer Investigational Site
Amos, Quebec, J9T 1T8
Pfizer Investigational Site
Brampton, Ontario, L6T 3J1
Pfizer Investigational Site
Burlington, Ontario, L7M 4Y1
Pfizer Investigational Site
Calgary, Alberta, T2E 7C5
Pfizer Investigational Site
Calgary, Alberta, T3E 0C5
Pfizer Investigational Site
Calgary, Alberta, T3G 3J9
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 1L2
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3V9
Pfizer Investigational Site
Courtice, Ontario, L1E 3C3
Pfizer Investigational Site
Cowansville, Quebec, J2K 2X9
Pfizer Investigational Site
Downsview, Ontario, M3M 3E5
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8
Pfizer Investigational Site
Edmonton, Alberta, T5K 2A2
Pfizer Investigational Site
Edmonton, Alberta, T5N 2N8
Pfizer Investigational Site
Fort Erie, Ontario, L2A1Z3
Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2G8
Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2H1
Pfizer Investigational Site
Greenfield Park, Quebec, J4V2H1
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1Y6
Pfizer Investigational Site
Halifax, Nova Scotia, B3K 5R3
Pfizer Investigational Site
Halifax, B3K 5R3, Nova Scotia
Pfizer Investigational Site
Hamilton, Ontario, L8M 1K7
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Kitchener, Ontario, N2C 2N9
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
Laval, Quebec, H7N 2k2
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
Laval, Quebec, H7V 2W3
Pfizer Investigational Site
Le Gardeur, Quebec, J5Z 3C4
Pfizer Investigational Site
Lindsay, Ontario, K9V 6C5
Pfizer Investigational Site
Markham, Ontario, L6B 1A1
Pfizer Investigational Site
Midland, Ontario, L4R 4P4
Pfizer Investigational Site
Moncton, New Brunswick, E1G 1A7
Pfizer Investigational Site
Montague, Prince Edward Island, C0A 1R0
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Montreal, Quebec, H3S 2W1
Pfizer Investigational Site
Montreal, Quebec, H4N 2W2
Pfizer Investigational Site
Montreal, Quebec, H4V 2R8
Pfizer Investigational Site
Napanee, Ontario, K7R 2G3
Pfizer Investigational Site
Newmarket, Ontario, L3Y 5G8
Pfizer Investigational Site
Niagara Falls, Ontario, L2E 7H1
Pfizer Investigational Site
North Bay, Ontario, P1B 2H3
Pfizer Investigational Site
North York, Ontario, M3J 1N2
Pfizer Investigational Site
Oshawa, Ontario, L1H 1B9
Pfizer Investigational Site
Oshawa, Ontario, L1J 2K9
Pfizer Investigational Site
Ottawa, Ontario, K1C 1S6
Pfizer Investigational Site
Plessisville, Quebec, G6L 3J1
Pfizer Investigational Site
Québec, Quebec, G1S 2L6
Pfizer Investigational Site
Regina, Saskatchewan, S4P 3X1
Pfizer Investigational Site
Rothesay, New Brunswick, E2E 2R2
Pfizer Investigational Site
Saint Catherines, Ontario, L2N 7H8
Pfizer Investigational Site
Saint Catherines, Ontario, L2S 3V7
Pfizer Investigational Site
Saint John, New Brunswick, E2K 2T8
Pfizer Investigational Site
Saint-Eustache, Quebec, J7P 2V1
Pfizer Investigational Site
Saint-Léonard, Quebec, H1S 3A9
Pfizer Investigational Site
Salaberry Du Valleyfield, Quebec, J6S 4Z5
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7H 0W6
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0H6
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 1N8
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7L 2W1
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 4J6
Pfizer Investigational Site
St. John's, A1E 2C2
Pfizer Investigational Site
St. John's, A1E 2E2
Pfizer Investigational Site
Ste. Foy, Quebec, G1V 4G2
Pfizer Investigational Site
Surrey, British Columbia, V3R 3P1
Pfizer Investigational Site
Thornhill, Ontario, L3T 4X1
Pfizer Investigational Site
Thunder Bay, Ontario, P7E 4Z3
Pfizer Investigational Site
Thunder Bay, Ontario, P7E 6E7
Pfizer Investigational Site
Toronto, Ontario, M5C 2T2
Pfizer Investigational Site
Toronto, Ontario, M5G 2C4
Pfizer Investigational Site
Toronto, Ontario, M8V 3X8
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 3J5
Pfizer Investigational Site
Vaudreuil, Quebec, J7V 8P9
Pfizer Investigational Site
Victoria, British Columbia, V8T 3P2
Pfizer Investigational Site
Windsor, Ontario, N8X 1K4
Pfizer Investigational Site
Winnipeg, Manitoba, R2V 3P4
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this 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.

Conditions: Hypercholesterolemia
Being tested: atorvastatin
Keywords: (D006937)
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

atorvastatinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004May 2005

First posted8 Sep 2005 (estimated)
Study startJun 2004
Study completionMay 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,100 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00150371
Sponsor's protocol ID: A2581091
Acronym: CANACTFAST
Status last verified: Feb 2021
First submitted: 6 Sep 2005
Last updated: 18 Feb 2021
Results posted: No

Publications

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.
PubMed 20151053

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00150371
Acronym / sponsor ID: CANACTFAST / A2581091
Conditions: Hypercholesterolemia
Keywords: (D006937)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,100 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jun 2004
Study completion: May 2005 (actual)
First posted: 8 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 30 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
atorvastatin	Drug	–

Primary outcome

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).

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Derived from this study: PubMed 20151053Ur 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.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

84 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing atorvastatin in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 84 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00150371, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.