Coronary Heart Disease Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
NCT number | NCT00300469 |
Other study ID # | M05-750 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | March 7, 2006 |
Last updated | June 1, 2009 |
Start date | March 2006 |
Verified date | June 2009 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug AdministrationCanada: Health Canada |
Study type | Interventional |
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
Status | Completed |
Enrollment | 613 |
Est. completion date | |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects with mixed dyslipidemia - Subjects must agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet Exclusion Criteria: - Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial. - Patients who are taking certain medications or unstable dose of specific medications. - Women who are pregnant or plan on becoming pregnant, or women who are lactating. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Global Medical Information | North Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Percent Change in Triglycerides From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Primary | Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Primary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Secondary | Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Secondary | Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Secondary | Mean Percent Change in Total Cholesterol From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Secondary | Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No | |
Secondary | Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit | Baseline to 12 Weeks (Final Visit) | No |
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