ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00300482
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : March 25, 2009
Last Update Posted : June 10, 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) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium 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: Rosuvastatin Calcium Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1445 participants
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 Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
Study Start Date : March 2006
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
ABT-335 + 10 mg rosuvastatin
Drug: ABT-335
135 mg, daily, 12 weeks
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
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
Drug: Placebo
Daily, 12 weeks, see Arm Description for information regarding placebo type
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
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
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



Primary Outcome Measures :
  1. Mean Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
  2. Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
  3. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]

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


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:

  • 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.

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): 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

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

Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00300482     History of Changes
Other Study ID Numbers: M05-748
First Posted: March 9, 2006    Key Record Dates
Results First Posted: March 25, 2009
Last Update Posted: June 10, 2009
Last Verified: June 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
Calcium, Dietary
Rosuvastatin Calcium
Fenofibric acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors