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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:
ClinicalTrials.gov Identifier:
NCT00300469
First Posted: March 9, 2006
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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) ]
  • Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  • Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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) ]
  • Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  • Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  • Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  • Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 7, 2006
First Posted: March 9, 2006
Results First Submitted: January 14, 2009
Results First Posted: March 25, 2009
Last Update Posted: July 29, 2009
Last Verified: June 2009

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