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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

Primary Purpose

Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-335
Rosuvastatin Calcium
Placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Global Medical Information

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

A

B

C

D

E

F

Arm Description

ABT-335 + 10 mg rosuvastatin

ABT-335 + 20 mg rosuvastatin

ABT-335 monotherapy

10 mg rosuvastatin monotherapy

20 mg rosuvastatin monotherapy

40 mg rosuvastatin monotherapy

Outcomes

Primary Outcome Measures

Mean Percent Change in Triglycerides From Baseline to Final Visit
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100

Secondary Outcome Measures

Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100

Full Information

First Posted
March 7, 2006
Last Updated
June 3, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00300482
Brief Title
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
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 Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Keywords
Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
ABT-335 + 10 mg rosuvastatin
Arm Title
B
Arm Type
Active Comparator
Arm Description
ABT-335 + 20 mg rosuvastatin
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
ABT-335 monotherapy
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
10 mg rosuvastatin monotherapy
Arm Title
E
Arm Type
Placebo Comparator
Arm Description
20 mg rosuvastatin monotherapy
Arm Title
F
Arm Type
Placebo Comparator
Arm Description
40 mg rosuvastatin monotherapy
Intervention Type
Drug
Intervention Name(s)
ABT-335
Intervention Description
135 mg, daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin Calcium
Other Intervention Name(s)
Rosuvastatin
Intervention Description
Daily, 12 weeks, see Arm Description for dosage information
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily, 12 weeks, see Arm Description for information regarding placebo type
Primary Outcome Measure Information:
Title
Mean Percent Change in Triglycerides From Baseline to Final Visit
Description
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
Description
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
Description
[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100
Time Frame
Baseline to 12 Weeks
Secondary Outcome Measure Information:
Title
Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
Description
[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
Description
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
Description
[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
Description
[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100
Time Frame
Baseline to 12 Weeks
Title
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
Description
[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100
Time Frame
Baseline to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Kelly, MD
Organizational Affiliation
Abbott
Official's Role
Principal Investigator
Facility Information:
Facility Name
Global Medical Information
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22263674
Citation
Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25. doi: 10.2165/11597940-000000000-00000.
Results Reference
derived
PubMed Identifier
21174145
Citation
Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57. doi: 10.1007/s10557-010-6273-5.
Results Reference
derived
PubMed Identifier
20573750
Citation
Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. doi: 10.2337/dc10-0357. Epub 2010 Jun 23.
Results Reference
derived
PubMed Identifier
20136164
Citation
Jones PH, Cusi K, Davidson MH, Kelly MT, Setze CM, Thakker K, Sleep DJ, Stolzenbach JC. Efficacy and safety of fenofibric acid co-administered with low- or moderate-dose statin in patients with mixed dyslipidemia and type 2 diabetes mellitus: results of a pooled subgroup analysis from three randomized, controlled, double-blind trials. Am J Cardiovasc Drugs. 2010;10(2):73-84. doi: 10.2165/10061630-000000000-00000.
Results Reference
derived
PubMed Identifier
18996523
Citation
Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5.
Results Reference
derived
PubMed Identifier
18783301
Citation
Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34. doi: 10.2165/00044011-200828100-00003.
Results Reference
derived

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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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