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Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00300469
First received: March 7, 2006
Last updated: June 1, 2009
Last verified: June 2009
  Purpose
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.

Condition Intervention Phase
Mixed Dyslipidemia
Coronary Heart Disease
Dyslipidemia
Drug: ABT-335
Drug: Atorvastatin
Drug: Placebo
Phase 3

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 Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia

Resource links provided by NLM:


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 (Final Visit) ] [ 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 (Final Visit) ] [ 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 (Final Visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ 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 (Final Visit) ] [ Designated as safety issue: No ]
  • Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ 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 (Final Visit) ] [ 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 (Final Visit) ] [ Designated as safety issue: No ]

Enrollment: 613
Study Start Date: March 2006
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
ABT-335 + 20 mg atorvastatin
Drug: ABT-335
135 mg, daily, 12 weeks
Drug: Atorvastatin
Daily, 12 weeks, see Arm Description for dosage information
Active Comparator: B
ABT-335 + 40 mg atorvastatin
Drug: ABT-335
135 mg, daily, 12 weeks
Drug: Atorvastatin
Daily, 12 weeks, see Arm Description for dosage information
Placebo Comparator: C
ABT-335 monotherapy
Drug: ABT-335
135 mg, daily, 12 weeks
Drug: Placebo
daily, 12 weeks, see Arm Description for placebo information
Placebo Comparator: D
20 mg atorvastatin monotherapy
Drug: Atorvastatin
Daily, 12 weeks, see Arm Description for dosage information
Drug: Placebo
daily, 12 weeks, see Arm Description for placebo information
Placebo Comparator: E
40 mg atorvastatin monotherapy
Drug: Atorvastatin
Daily, 12 weeks, see Arm Description for dosage information
Drug: Placebo
daily, 12 weeks, see Arm Description for placebo information
Placebo Comparator: F
80 mg atorvastatin monotherapy
Drug: Atorvastatin
Daily, 12 weeks, see Arm Description for dosage information
Drug: Placebo
daily, 12 weeks, see Arm Description for placebo information

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300469

Locations
United States, Illinois
Global Medical Information
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00300469     History of Changes
Other Study ID Numbers: M05-750 
Study First Received: March 7, 2006
Results First Received: January 14, 2009
Last Updated: June 1, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Abbott:
Mixed Dyslipidemia
Coronary Heart Disease
Dyslipidemia

Additional relevant MeSH terms:
Heart Diseases
Dyslipidemias
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin Calcium
Fenofibric acid
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016