Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. - Full Text View

Purpose

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Condition	Intervention	Phase
Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia	Drug: ABT-335 and rosuvastatin calcium Drug: ABT-335 and atorvastatin calcium Drug: ABT-335 and simvastatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Calcium Coronary Artery Disease Heart Diseases Statins

Drug Information available for: Calcium Gluconate Fenofibrate Simvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-Blind Studies or in This Open-Label Study [ Time Frame: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]
Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-Label Study [ Time Frame: Baseline to Week 52 in this open-label study ] [ Designated as safety issue: No ]
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]
Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Week 52 of the Open-Label Study [ Time Frame: Baseline to Week 52 of the open-label study ] [ Designated as safety issue: No ]

Enrollment:	1911
Study Start Date:	September 2006
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A 20 mg drug and ABT-335	Drug: ABT-335 and rosuvastatin calcium ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks Other Names: ABT-335 TRILIPIX
Active Comparator: B 40 mg drug and ABT 335	Drug: ABT-335 and atorvastatin calcium ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks Other Names: ABT-335 TRILIPIX
Active Comparator: C 40 mg drug and ABT-335	Drug: ABT-335 and simvastatin ABT-335 135 mg plus simvastatin daily, 52 weeks Other Names: ABT-335 TRILIPIX

Eligibility

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

Criteria

Inclusion Criteria:

Adult male and female subjects who voluntarily sign the informed consent.
Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Exclusion Criteria:

Subject is using or will use investigational medications, except as approved by Abbott.
Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300430

Locations

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

Sponsors and Collaborators

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):

Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25. doi: 10.2165/11597940-000000000-00000.

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:	NCT00300430 History of Changes
Other Study ID Numbers:	M05-758
Study First Received:	March 7, 2006
Results First Received:	March 10, 2009
Last Updated:	June 3, 2009
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

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
Simvastatin

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

ClinicalTrials.gov processed this record on May 23, 2013