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

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ClinicalTrials.gov Identifier: NCT00300456
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : March 25, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Abbott

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia Drug: ABT-335 Drug: Simvastatin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 657 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia
Study Start Date : March 2006
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Active Comparator: A
ABT-335 + 20 mg simvastatin
Drug: ABT-335
135 mg, daily, 12 weeks

Drug: Simvastatin
daily, 12 weeks, see Arm Description for dosage information

Active Comparator: B
ABT-335 + 40 mg simvastatin
Drug: ABT-335
135 mg, daily, 12 weeks

Drug: Simvastatin
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 simvastatin monotherapy
Drug: Simvastatin
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 simvastatin monotherapy
Drug: Simvastatin
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 simvastatin monotherapy
Drug: Simvastatin
daily, 12 weeks, see Arm Description for dosage information

Drug: Placebo
Daily, 12 weeks, see Arm Description for placebo information




Primary Outcome Measures :
  1. Mean Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  2. Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  3. 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 :
  1. 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) ]
  2. Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  3. Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  4. Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
  5. Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with mixed dyslipidemia
  • Subjects 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.

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): NCT00300456


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00300456     History of Changes
Other Study ID Numbers: M05-749
First Posted: March 9, 2006    Key Record Dates
Results First Posted: March 25, 2009
Last Update Posted: June 3, 2009
Last Verified: May 2009

Keywords provided by Abbott:
Dyslipidemia
Coronary Heart Disease
Mixed 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
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors