Hypercholesterolemia Clinical Trial
Official title:
A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
| NCT number | NCT00141141 |
| Other study ID # | A2581053 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | January 2004 |
| Est. completion date | April 2007 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.
| Status | Completed |
| Enrollment | 383 |
| Est. completion date | April 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus - LDL-C > 130 mg/dL Exclusion Criteria: - Insulin therapy - Clinically relevant organ disease (creatininemia >2mg/dL, CHF NYHA III and IV) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Pfizer Investigational Site | Ancona | |
| Italy | Pfizer Investigational Site | Asti | |
| Italy | Pfizer Investigational Site | Bari | |
| Italy | Pfizer Investigational Site | Cagliari | |
| Italy | Pfizer Investigational Site | Campobasso | |
| Italy | Pfizer Investigational Site | Casarano | Lecce |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Catanzaro | |
| Italy | Pfizer Investigational Site | Ferrara | |
| Italy | Pfizer Investigational Site | Genova | |
| Italy | Pfizer Investigational Site | Messina | |
| Italy | Pfizer Investigational Site | Mestre | VE |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Orbassano | Torino |
| Italy | Pfizer Investigational Site | Palermo | |
| Italy | Pfizer Investigational Site | Parma | |
| Italy | Pfizer Investigational Site | Pavia | PV |
| Italy | Pfizer Investigational Site | Perugia | |
| Italy | Pfizer Investigational Site | Pisa | |
| Italy | Pfizer Investigational Site | Potenza | |
| Italy | Pfizer Investigational Site | Rimini | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | S. Benedetto DEL Tronto | Ascoli Piceno |
| Italy | Pfizer Investigational Site | S. Benedetto Del Tronto (AP) | |
| Italy | Pfizer Investigational Site | S.Pietro Vernotico | Brindisi |
| Italy | Pfizer Investigational Site | Torino | |
| Italy | Pfizer Investigational Site | Udine |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the decrease of LDL-C after 24 weeks of treatment. | |||
| Secondary | To evaluate the changes from baseline of targeted blood markers. | |||
| Secondary | To evaluate safety of Atorvastatin vs Simvastatin |
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