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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

Primary Purpose

Mixed Dyslipidemia, Coronary Heart Disease, Dyslipidemia

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

About this trial

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

Eligibility Criteria

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

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.

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 + 20 mg atorvastatin

ABT-335 + 40 mg atorvastatin

ABT-335 monotherapy

20 mg atorvastatin monotherapy

40 mg atorvastatin monotherapy

80 mg atorvastatin 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-high-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 1, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00300469
Brief Title
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin 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 Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin 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
February 2007 (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) + atorvastatin combination therapy with ABT-335 and atorvastatin 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
Mixed Dyslipidemia, Coronary Heart Disease, Dyslipidemia
Keywords
Mixed Dyslipidemia, Coronary Heart Disease, Dyslipidemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
ABT-335 + 20 mg atorvastatin
Arm Title
B
Arm Type
Active Comparator
Arm Description
ABT-335 + 40 mg atorvastatin
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
ABT-335 monotherapy
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
20 mg atorvastatin monotherapy
Arm Title
E
Arm Type
Placebo Comparator
Arm Description
40 mg atorvastatin monotherapy
Arm Title
F
Arm Type
Placebo Comparator
Arm Description
80 mg atorvastatin monotherapy
Intervention Type
Drug
Intervention Name(s)
ABT-335
Intervention Description
135 mg, daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
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 placebo information
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 (Final Visit)
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 (Final Visit)
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 (Final Visit)
Secondary Outcome Measure Information:
Title
Mean Percent Change in Non-high-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 (Final Visit)
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 (Final Visit)
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 (Final Visit)
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 (Final Visit)
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 (Final Visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
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
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 Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

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