Status:
COMPLETED
Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
30-79 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Age 30 to 79 years old
- Triglyceride level 6.8 mmol/L at screening
- LDL-C of 5.7 mmol/L at screening
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00150371
Start Date
June 1 2004
End Date
May 1 2005
Last Update
February 18 2021
Active Locations (84)
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1
Pfizer Investigational Site
Calgary, Alberta, Canada, T2E 7C5
2
Pfizer Investigational Site
Calgary, Alberta, Canada, T3E 0C5
3
Pfizer Investigational Site
Calgary, Alberta, Canada, T3G 3J9
4
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5A 4L8