Hypercholesterolemia Clinical Trial
— CAPOfficial title:
A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis
| NCT number | NCT00163202 |
| Other study ID # | A2581065 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | June 2002 |
| Est. completion date | August 2005 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.
| Status | Completed |
| Enrollment | 330 |
| Est. completion date | August 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Male or female subjects of age of majority to < 80 years - Subjects with LDL-C > 0.5 g/L (1.29 mmol/L) and < 1.5 g/L (3.87 mmol/L), TG < 4.00 g/L (4.56 mmol/L) and hs-CRP >1.5 mg/L and < 15 mg/L - Subjects with a documented coronary artery disease. Exclusion Criteria: - Female subjects of childbearing potential without contraception - Subjects with secondary hyperlipidemia - Diabetic subjects receiving insulin - Subjects with a contra-indication to statin therapy. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Chicoutimi | Quebec |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | London | Ontario |
| 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 | Oshawa | Ontario |
| Canada | Pfizer Investigational Site | Sarnia | Ontario |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
| Canada | Pfizer Investigational Site | Ste-foy | Quebec |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Weston | Ontario |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Czechia | Pfizer Investigational Site | Brno-Bohunice | |
| Czechia | Pfizer Investigational Site | Jindrichuv Hradec | |
| Czechia | Pfizer Investigational Site | Prague 2 | |
| Czechia | Pfizer Investigational Site | Prague 2 | |
| Czechia | Pfizer Investigational Site | Prague 5 | |
| France | Pfizer Investigational Site | Besancon | |
| France | Pfizer Investigational Site | Brest | |
| France | Pfizer Investigational Site | Chambery | |
| France | Pfizer Investigational Site | Clamart | |
| France | Pfizer Investigational Site | Clermont-ferrand | |
| France | Pfizer Investigational Site | Clermont-ferrand | Cedex |
| France | Pfizer Investigational Site | Creil | |
| France | Pfizer Investigational Site | Dijon | |
| France | Pfizer Investigational Site | Evecquemont | |
| France | Pfizer Investigational Site | GAP | |
| France | Pfizer Investigational Site | Henin-beaumont | |
| France | Pfizer Investigational Site | Langres | Cedex |
| France | Pfizer Investigational Site | Le Kremlin Bicetre Cedex | |
| France | Pfizer Investigational Site | Lille | |
| France | Pfizer Investigational Site | Marseille Cedex 05 | |
| France | Pfizer Investigational Site | Metz Cedex 01 | |
| France | Pfizer Investigational Site | Monaco | |
| France | Pfizer Investigational Site | Montpellier | |
| France | Pfizer Investigational Site | Mulhouse | |
| France | Pfizer Investigational Site | Nancy | |
| France | Pfizer Investigational Site | Nantes Saint Herblain | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris Cedex 05 | |
| France | Pfizer Investigational Site | Paris Cedex 15 | |
| France | Pfizer Investigational Site | Paris Cedex 18 | |
| France | Pfizer Investigational Site | Pessac | |
| France | Pfizer Investigational Site | Poissy | |
| France | Pfizer Investigational Site | Pontoise | |
| France | Pfizer Investigational Site | Roubaix | |
| France | Pfizer Investigational Site | Saint Michel | |
| France | Pfizer Investigational Site | Thionville | |
| France | Pfizer Investigational Site | Toulouse | |
| France | Pfizer Investigational Site | Tourcoing | |
| France | Pfizer Investigational Site | Vandoeuvre | |
| France | Pfizer Investigational Site | Vandoeuvre Les Nancy | |
| Poland | Pfizer Investigational Site | Belchatow | |
| Poland | Pfizer Investigational Site | Gdynia | |
| Poland | Pfizer Investigational Site | Rawa Mazowiecka | |
| Poland | Pfizer Investigational Site | Torun | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Poland | Pfizer Investigational Site | Zamosc | |
| Romania | Pfizer Investigational Site | Bucharest | Sector 2 |
| Romania | Pfizer Investigational Site | Bucharest | Sector 2 |
| Romania | Pfizer Investigational Site | Bucharest | Sector 5 |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Volgograd | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Bratislava |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Bio-Inova Life Sciences International, MDS Pharma Services |
Canada, Czechia, France, Poland, Romania, Russian Federation, Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5). | |||
| Secondary | 1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at |
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