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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | ABT-335 + 10 mg rosuvastatin |
|
| B | Active Comparator | ABT-335 + 20 mg rosuvastatin |
|
| C | Placebo Comparator | ABT-335 monotherapy |
|
| D | Placebo Comparator | 10 mg rosuvastatin monotherapy |
|
| E | Placebo Comparator | 20 mg rosuvastatin monotherapy |
|
| F | Placebo Comparator | 40 mg rosuvastatin 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 12 Weeks |
| 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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| Name | Affiliation | Role |
|---|---|---|
| Maureen Kelly, MD | Abbott | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Medical Information | North Chicago | Illinois | 60064 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22263674 | Derived | 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. | |
| 21174145 | Derived | 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. |
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Six subjects were randomized but not treated: 1 was lost to follow-up, 1 was randomized but deemed ineligible, 1 was withdrawn at the investigator's discretion, and 3 withdrew consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-335 + 10 mg Rosuvastatin | ABT-335 + 10 mg rosuvastatin combination therapy once daily |
| FG001 | ABT-335 + 20 mg Rosuvastatin | ABT-335 + 20 mg rosuvastatin combination therapy once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rosuvastatin Calcium |
| Drug |
Daily, 12 weeks, see Arm Description for dosage information |
|
|
| Placebo | Drug | Daily, 12 weeks, see Arm Description for information regarding placebo type |
|
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100 |
| Baseline to 12 Weeks |
| 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 |
| 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 |
| 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 |
| 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 | Derived | 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. |
| 18996523 | Derived | 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. |
| 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 | 10 mg Rosuvastatin | 10 mg rosuvastatin monotherapy once daily |
| FG004 | 20 mg Rosuvastatin | 20 mg rosuvastatin monotherapy once daily |
| FG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-335 + 10 mg Rosuvastatin | ABT-335 + 10 mg rosuvastatin combination therapy once daily |
| BG001 | ABT-335 + 20 mg Rosuvastatin | ABT-335 + 20 mg rosuvastatin combination therapy once daily |
| BG002 | ABT-335 | ABT-335 monotherapy once daily |
| BG003 | 10 mg Rosuvastatin | 10 mg rosuvastatin monotherapy once daily |
| BG004 | 20 mg Rosuvastatin | 20 mg rosuvastatin monotherapy once daily |
| BG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 and at least 1 postbaseline ApoB value, LOCF | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
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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 + 10 mg Rosuvastatin | ABT-335 + 10 mg rosuvastatin combination therapy once daily | 10 | 126 | ||||
| EG001 | ABT-335 + 20 mg Rosuvastatin | ABT-335 + 20 mg rosuvastatin combination therapy once daily | 3 | 114 | ||||
| EG002 | ABT-335 | ABT-335 monotherapy once daily | 10 | 117 | ||||
| EG003 | 10 mg Rosuvastatin | 10 mg rosuvastatin monotherapy once daily | 3 | 109 | ||||
| EG004 | 20 mg Rosuvastatin | 20 mg rosuvastatin monotherapy once daily | 7 | 110 | ||||
| EG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily | 2 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA 9 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Stomach discomfort | 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 |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper respiratiory tract infection | Infections and infestations | 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 |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteoarthritis | 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 |
| |
| Insomnia | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C533234 | 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
An n = 205 per arm would provide >99% power to detect a 17% 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 |
20 mg rosuvastatin monotherapy once daily
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|
|
20 mg rosuvastatin monotherapy once daily
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|
|
20 mg rosuvastatin monotherapy once daily
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|
20 mg rosuvastatin monotherapy once daily
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|
20 mg rosuvastatin monotherapy once daily
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|
20 mg rosuvastatin monotherapy once daily
| OG005 | 40 mg Rosuvastatin | 40 mg rosuvastatin monotherapy once daily |
|
|