Back to resultsStudy to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Primary Purpose
Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-335 and rosuvastatin calcium
ABT-335 and atorvastatin calcium
ABT-335 and simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
Inclusion Criteria: Adult male and female subjects who voluntarily sign the informed consent. Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies. Exclusion Criteria: Subject is using or will use investigational medications, except as approved by Abbott. Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
Sites / Locations
- Global Medical Information
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
A
B
C
Arm Description
20 mg drug and ABT-335
40 mg drug and ABT 335
40 mg drug and ABT-335
Outcomes
Primary Outcome Measures
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
Secondary Outcome Measures
Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00300430
Brief Title
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Official Title
A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2008 (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 primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1911 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
20 mg drug and ABT-335
Arm Title
B
Arm Type
Active Comparator
Arm Description
40 mg drug and ABT 335
Arm Title
C
Arm Type
Active Comparator
Arm Description
40 mg drug and ABT-335
Intervention Type
Drug
Intervention Name(s)
ABT-335 and rosuvastatin calcium
Other Intervention Name(s)
ABT-335, TRILIPIX
Intervention Description
ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-335 and atorvastatin calcium
Other Intervention Name(s)
ABT-335, TRILIPIX
Intervention Description
ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-335 and simvastatin
Other Intervention Name(s)
ABT-335, TRILIPIX
Intervention Description
ABT-335 135 mg plus simvastatin daily, 52 weeks
Primary Outcome Measure Information:
Title
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
Time Frame
Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy
Secondary Outcome Measure Information:
Title
Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
Title
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
Title
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
Title
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
Time Frame
Baseline to Week 52 in this open-label study
Title
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
Title
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
Title
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
Title
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
Time Frame
Baseline to Week 52 of the open-label study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male and female subjects who voluntarily sign the informed consent.
Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.
Exclusion Criteria:
Subject is using or will use investigational medications, except as approved by Abbott.
Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
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
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
Learn more about this trial
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
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