Hypercholesterolemia Clinical Trial
— CANACTFASTOfficial 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.
| NCT number | NCT00150371 |
| Other study ID # | A2581091 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | June 2004 |
| Est. completion date | May 2005 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1100 |
| Est. completion date | May 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 79 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Amos | Quebec |
| Canada | Pfizer Investigational Site | Brampton | Ontario |
| Canada | Pfizer Investigational Site | Burlington | Ontario |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Charlottetown | Prince Edward Island |
| Canada | Pfizer Investigational Site | Chicoutimi | Quebec |
| Canada | Pfizer Investigational Site | Coquitlam | British Columbia |
| Canada | Pfizer Investigational Site | Coquitlam | British Columbia |
| Canada | Pfizer Investigational Site | Courtice | Ontario |
| Canada | Pfizer Investigational Site | Cowansville | Quebec |
| Canada | Pfizer Investigational Site | Downsview | Ontario |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Fort Erie | Ontario |
| Canada | Pfizer Investigational Site | Greenfield Park | Quebec |
| Canada | Pfizer Investigational Site | Greenfield Park | Quebec |
| Canada | Pfizer Investigational Site | Greenfield Park | Quebec |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Halifax, B3K 5R3 | Nova Scotia |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | Hawkesbury | Ontario |
| Canada | Pfizer Investigational Site | Kelowna | British Columbia |
| Canada | Pfizer Investigational Site | Kitchener | Ontario |
| Canada | Pfizer Investigational Site | Langley | British Columbia |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Le Gardeur | Quebec |
| Canada | Pfizer Investigational Site | Lindsay | Ontario |
| Canada | Pfizer Investigational Site | Markham | Ontario |
| Canada | Pfizer Investigational Site | Midland | Ontario |
| Canada | Pfizer Investigational Site | Moncton | New Brunswick |
| Canada | Pfizer Investigational Site | Montague | Prince Edward Island |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Napanee | Ontario |
| Canada | Pfizer Investigational Site | Newmarket | Ontario |
| Canada | Pfizer Investigational Site | Niagara Falls | Ontario |
| Canada | Pfizer Investigational Site | North Bay | Ontario |
| Canada | Pfizer Investigational Site | North York | Ontario |
| Canada | Pfizer Investigational Site | Oshawa | Ontario |
| Canada | Pfizer Investigational Site | Oshawa | Ontario |
| Canada | Pfizer Investigational Site | Ottawa | Ontario |
| Canada | Pfizer Investigational Site | Plessisville | Quebec |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Regina | Saskatchewan |
| Canada | Pfizer Investigational Site | Rothesay | New Brunswick |
| Canada | Pfizer Investigational Site | Saint Catherines | Ontario |
| Canada | Pfizer Investigational Site | Saint John | New Brunswick |
| Canada | Pfizer Investigational Site | Saint-Eustache | Quebec |
| Canada | Pfizer Investigational Site | Salaberry Du Valleyfield | Quebec |
| Canada | Pfizer Investigational Site | Sarnia | Ontario |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
| Canada | Pfizer Investigational Site | St. Catherines | Ontario |
| Canada | Pfizer Investigational Site | St. John's | |
| Canada | Pfizer Investigational Site | St. John's | |
| Canada | Pfizer Investigational Site | St. Leonard | Quebec |
| Canada | Pfizer Investigational Site | Ste. Foy | Quebec |
| Canada | Pfizer Investigational Site | Surrey | British Columbia |
| Canada | Pfizer Investigational Site | Thornhill | Ontario |
| Canada | Pfizer Investigational Site | Thunder Bay | Ontario |
| Canada | Pfizer Investigational Site | Thunder Bay | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Vaudreuil | Quebec |
| Canada | Pfizer Investigational Site | Victoria | British Columbia |
| Canada | Pfizer Investigational Site | Windsor | Ontario |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
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