Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00300482

Purpose

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.

Condition	Intervention	Phase
Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia	Drug: ABT-335 Drug: Rosuvastatin Calcium Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Rosuvastatin calcium Rosuvastatin Calcium gluconate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Mean Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean Percent Change in Non-Low-Density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	1445
Study Start Date:	March 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A ABT-335 + 10 mg rosuvastatin	Drug: ABT-335 135 mg, daily, 12 weeks Other Name: ABT-335 Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Other Name: Rosuvastatin
Active Comparator: B ABT-335 + 20 mg rosuvastatin	Drug: ABT-335 135 mg, daily, 12 weeks Other Name: ABT-335 Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Other Name: Rosuvastatin
Placebo Comparator: C ABT-335 monotherapy	Drug: ABT-335 135 mg, daily, 12 weeks Other Name: ABT-335 Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type Other Name: Placebo
Placebo Comparator: D 10 mg rosuvastatin monotherapy	Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Other Name: Rosuvastatin Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type Other Name: Placebo
Placebo Comparator: E 20 mg rosuvastatin monotherapy	Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Other Name: Rosuvastatin Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type Other Name: Placebo
Placebo Comparator: F 40 mg rosuvastatin monotherapy	Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Other Name: Rosuvastatin Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type Other Name: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with mixed dyslipidemia

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300482

Locations

United States, Illinois
Global Medical Information
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Principal Investigator:

Maureen Kelly, MD

Abbott

More Information

Additional Information:

You can access information on these products by clicking on the product name. This link exits the ClinicalTrials.gov site

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57.

Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. Epub 2010 Jun 23.

Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. Epub 2008 Oct 5.

Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34.

Responsible Party:	Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00300482 History of Changes
Other Study ID Numbers:	M05-748
Study First Received:	March 7, 2006
Results First Received:	January 14, 2009
Last Updated:	June 3, 2009
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Abbott:

Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Dyslipidemias
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Fenofibric acid

Rosuvastatin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012