Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 20 mg drug and ABT-335 |
|
| B | Active Comparator | 40 mg drug and ABT 335 |
|
| C | Active Comparator | 40 mg drug and ABT-335 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-335 and rosuvastatin calcium | Drug | ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | |
| 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. |
Not provided
Not provided
1895 subjects were treated in this study. 306 others who did not enroll in this study but were treated with combo therapy in preceding double-blind studies are included in analyses of adverse events. Six subjects were enrolled, but never received study drug. An additional 10 subjects from a site that was closed were not included in any analysis.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABT-335 + 20 mg Rosuvastatin | ABT-335 and 20 mg rosuvastatin combination therapy |
| FG001 | ABT-335 + 40 mg Simvastatin | ABT-335 and 40 mg simvastatin combination therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ABT-335 and atorvastatin calcium | Drug | ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks |
|
|
| ABT-335 and simvastatin | Drug | ABT-335 135 mg plus simvastatin daily, 52 weeks |
|
|
| 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 | 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 | 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 | 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 | 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 | 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 | Baseline to Week 52 of the open-label study |
| FG002 | ABT-335 + 40 mg Atorvastatin | ABT-335 and 40 mg atorvastatin combination therapy |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABT-335 + 20 mg Rosuvastatin | ABT-335 and 20 mg rosuvastatin combination therapy |
| BG001 | ABT-335 + 40 mg Simvastatin | ABT-335 and 40 mg simvastatin combination therapy |
| BG002 | ABT-335 + 40 mg Atorvastatin | ABT-335 and 40 mg atorvastatin combination therapy |
| BG003 | 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 |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Median | Full Range | percent change | Baseline to Week 52 of the open-label study |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 of the open-label study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 of the open-label study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 in this open-label study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 of the open-label study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 of the open-label study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 of the open-label study |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized. | Posted | Number | percentage of participants | 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 | Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study | Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values. | Posted | Median | Full Range | percent change | Baseline to Week 52 of the open-label study |
|
|
Not provided
Not provided
Not provided
| 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 Rosuvastatin | ABT-335 and 20 mg rosuvastatin combination therapy | 85 | 646 | ||||
| EG001 | ABT-335 + 40 mg Simvastatin | ABT-335 and 40 mg simvastatin combination therapy | 40 | 308 | ||||
| EG002 | ABT-335 + 40 mg Atorvastatin | ABT-335 and 40 mg atorvastatin combination therapy | 23 | 283 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Coronary artery disease | 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 |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arnold-Chiari malformation | Congenital, familial and genetic disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hyperparathyroidism primary | Endocrine disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Enterocele | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest discomfort | General 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 |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Latex allergy | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Post procedural hematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Post procedural sepsis | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Ultrasound kidney abnormal | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteoarthritis | 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 |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Carcinoid tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pituitary tumor benign | 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 |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Brain edema | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Glomerulonephritis proliferative | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Uterine pain | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast 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 |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 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 |
| |
| Bronchitis | 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 |
| |
| 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system 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 |
|
This was an open-label study designed to assess the longer-term safety of the combination therapies. Evaluation of efficacy outcomes was a secondary objective.
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 |
| D011345 | Fenofibrate |
| D000069059 | Atorvastatin |
| D019821 | Simvastatin |
| 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 |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D010636 | Phenols |
| D007659 | Ketones |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
|
|
|
|
|
|
|