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The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | ABT-335 + 20 mg simvastatin |
|
| B | Active Comparator | ABT-335 + 40 mg simvastatin |
|
| C | Placebo Comparator | ABT-335 monotherapy |
|
| D | Placebo Comparator | 20 mg simvastatin monotherapy |
|
| E | Placebo Comparator | 40 mg simvastatin monotherapy |
|
| F | Placebo Comparator | 80 mg simvastatin monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-335 | Drug | 135 mg, daily, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Triglycerides From Baseline to Final Visit | [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100 | Baseline to 12 Weeks (Final Visit) |
| 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 | Baseline to 12 Weeks (Final Visit) |
| 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 | Baseline to 12 Weeks (Final Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 12 Weeks (Final Visit) |
| Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Medical Information | North Chicago | Illinois | 60064 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20573750 | Derived | 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. | |
| 20136164 |
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Seven subjects were randomized but never treated: 2 were taking a prohibited concomitant medication, 1 did not meet the entry criteria for lipid levels, 1 had an abnormal baseline electrocardiogram, 1 was unable to swallow pills, and 2 withdrew consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-335 + 20 mg Simvastatin | ABT-335 + 20 mg simvastatin combination therapy once daily |
| FG001 | ABT-335 + 40 mg Simvastatin | ABT-335 + 40 mg simvastatin combination therapy once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Simvastatin |
| Drug |
daily, 12 weeks, see Arm Description for dosage information |
|
| Placebo | Drug | Daily, 12 weeks, see Arm Description for placebo information |
|
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100 |
| Baseline to 12 Weeks (Final Visit) |
| Mean Percent Change in Total Cholesterol From Baseline to Final Visit | [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100 | Baseline to 12 Weeks (Final Visit) |
| 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 | Baseline to 12 Weeks (Final Visit) |
| 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 | Baseline to 12 Weeks (Final Visit) |
| 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. |
| 18783301 | Derived | 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. |
| FG002 | ABT-335 | ABT-335 monotherapy once daily |
| FG003 | 20 mg Simvastatin | 20 mg simvastatin monotherapy once daily |
| FG004 | 40 mg Simvastatin | 40 mg simvastatin monotherapy once daily |
| FG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-335 + 20 mg Simvastatin | ABT-335 + 20 mg simvastatin combination therapy once daily |
| BG001 | ABT-335 + 40 mg Simvastatin | ABT-335 + 40 mg simvastatin combination therapy once daily |
| BG002 | ABT-335 | ABT-335 monotherapy once daily |
| BG003 | 20 mg Simvastatin | 20 mg simvastatin monotherapy once daily |
| BG004 | 40 mg Simvastatin | 40 mg simvastatin monotherapy once daily |
| BG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change in Triglycerides From Baseline to Final Visit | [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100 | All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Total Cholesterol From Baseline to Final Visit | [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100 | All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
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| Secondary | 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 | All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks (Final Visit) |
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| Secondary | 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 | All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF | Posted | Median | Inter-Quartile Range | percent change | Baseline to 12 Weeks (Final Visit) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-335 + 20 mg Simvastatin | ABT-335 + 20 mg simvastatin combination therapy once daily | 1 | 65 | ||||
| EG001 | ABT-335 + 40 mg Simvastatin | ABT-335 + 40 mg simvastatin combination therapy once daily | 3 | 72 | ||||
| EG002 | ABT-335 | ABT-335 monotherapy once daily | 6 | 67 | ||||
| EG003 | 20 mg Simvastatin | 20 mg simvastatin monotherapy once daily | 1 | 60 | ||||
| EG004 | 40 mg Simvastatin | 40 mg simvastatin monotherapy once daily | 1 | 65 | ||||
| EG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily | 2 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arterial hemorrhage | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyspepsia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
Not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall be so restricted after the expiration of twelve (12) months from completion of the studies at all sites. Any presentation or publication to be submitted to Sponsor (in draft of the same) for Sponsor review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Specialist | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C533234 | 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
An n = 92 per arm would provide >99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30% |
| ANCOVA |
| <0.001 |
alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses |
| 95 |
| No |
| Superiority or Other |
40 mg simvastatin monotherapy once daily
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|
|
40 mg simvastatin monotherapy once daily
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|
|
40 mg simvastatin monotherapy once daily
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|
40 mg simvastatin monotherapy once daily
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|
40 mg simvastatin monotherapy once daily
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|
40 mg simvastatin monotherapy once daily
| OG005 | 80 mg Simvastatin | 80 mg simvastatin monotherapy once daily |
|
|