Hypercholesterolaemia Clinical Trial
Official title:
Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
| NCT number | NCT00163163 |
| Other study ID # | A2581051 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | January 2003 |
| Est. completion date | July 2006 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | July 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Postmenopausal women defined as having Age =< 70 years with documented menopause - Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet - Triglycerides =< 4 g/l(4.52 mmol/l) - Informed, written consent Exclusion Criteria: - Age > 70 years - Unconfirmed menopause - Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within the last year - Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization - History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA - CPK levels > 3 times upper limit of normal - Body Mass Index >= 30 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Pfizer Investigational Site | Afsnee GENT | |
| Belgium | Pfizer Investigational Site | Assenede | |
| Belgium | Pfizer Investigational Site | Brussels | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Ertvelde | |
| Belgium | Pfizer Investigational Site | Gent | |
| Belgium | Pfizer Investigational Site | Linkebeek | |
| Belgium | Pfizer Investigational Site | Sint-niklaas | |
| Belgium | Pfizer Investigational Site | Tielt | |
| Belgium | Pfizer Investigational Site | Wetteren | |
| Belgium | Pfizer Investigational Site | Wondelgem | |
| France | Pfizer Investigational Site | Achenheim | |
| France | Pfizer Investigational Site | Ancerville | |
| France | Pfizer Investigational Site | Augny | |
| France | Pfizer Investigational Site | Bar Le Duc | |
| France | Pfizer Investigational Site | Boersch | |
| France | Pfizer Investigational Site | Bois-Colombes | |
| France | Pfizer Investigational Site | Boissy Saint Leger | |
| France | Pfizer Investigational Site | Bouzonville | |
| France | Pfizer Investigational Site | Colombey-Les-Belles | |
| France | Pfizer Investigational Site | Dammarie Les Lys | |
| France | Pfizer Investigational Site | Docelles | |
| France | Pfizer Investigational Site | Dourdan | |
| France | Pfizer Investigational Site | Eckbolsheim | |
| France | Pfizer Investigational Site | Epinay S/orge | |
| France | Pfizer Investigational Site | Etampes | |
| France | Pfizer Investigational Site | Frouard | |
| France | Pfizer Investigational Site | Gambsheim | |
| France | Pfizer Investigational Site | Haguenau | |
| France | Pfizer Investigational Site | Kilstett | |
| France | Pfizer Investigational Site | Laxou | |
| France | Pfizer Investigational Site | le Grand Quevilly | |
| France | Pfizer Investigational Site | Le Mesnil Esnard | |
| France | Pfizer Investigational Site | Leuville Sur Orge | |
| France | Pfizer Investigational Site | Lingolsheim | |
| France | Pfizer Investigational Site | Longpont Sur Orge | |
| France | Pfizer Investigational Site | Mars LA Tour | |
| France | Pfizer Investigational Site | Metz | |
| France | Pfizer Investigational Site | Moutiers | |
| France | Pfizer Investigational Site | Nancy | |
| France | Pfizer Investigational Site | Nancy | |
| France | Pfizer Investigational Site | Nancy | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Pont a Mousson | |
| France | Pfizer Investigational Site | Pont-a-mousson | |
| France | Pfizer Investigational Site | Pulnoy | |
| France | Pfizer Investigational Site | Rouen | |
| France | Pfizer Investigational Site | Sainte Genevieve Des Bois | |
| France | Pfizer Investigational Site | Sauvigny | |
| France | Pfizer Investigational Site | Savigny Sur Orge | |
| France | Pfizer Investigational Site | Sotteville Les Rouen Cedex | |
| France | Pfizer Investigational Site | Souffelweyersheim | |
| France | Pfizer Investigational Site | St Max | |
| France | Pfizer Investigational Site | Strasbourg | |
| France | Pfizer Investigational Site | Strasbourg | |
| France | Pfizer Investigational Site | Terville | |
| France | Pfizer Investigational Site | Toul | |
| France | Pfizer Investigational Site | Vandoeuvre | |
| France | Pfizer Investigational Site | Vandoeuvre Les Nancy | |
| France | Pfizer Investigational Site | Verdun | |
| France | Pfizer Investigational Site | Vincennes | |
| Netherlands | Pfizer Investigational Site | ED Voerendaal | |
| Netherlands | Pfizer Investigational Site | EN Vaals | |
| Netherlands | Pfizer Investigational Site | VE Maastricht |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Belgium, France, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in carotid IMT from baseline to month 12. | |||
| Secondary | Mean change from baseline to month 12 of carotid internal diameter (ID) | |||
| Secondary | wall cross sectional area (WCSA); carotid arterial mass (AM) | |||
| Secondary | pulse pressure (PP); cross sectional distensibility and compliance (DC and CC) | |||
| Secondary | pulse wave velocity (PWV); Lipid profile |
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