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

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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

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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

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 ]
    [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100

  2. Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
    [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100

  3. Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
    [(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100


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 ]
    [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100

  2. Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
    [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100

  3. Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
    [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100

  4. Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
    [(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100

  5. Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks ]
    [(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100



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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:

  • 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
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United States, Illinois
Global Medical Information
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
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Principal Investigator: Maureen Kelly, MD Abbott
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00300482    
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:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Dyslipidemias
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Rosuvastatin Calcium
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors