Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005_105 |
Not provided
Not provided
Not provided
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To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Atorvastatin 80 mg |
|
| 2 | Experimental | Atorvastatin 40 mg + ezetimibe 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C | Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) | Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 weeks |
| Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19026303 | Background | Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23. | |
| 21118495 |
Not provided
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Patients received and were blinded to atorvastatin 40 mg for a 4/5- week run-in period.
Patients needed an LDL-C ≥ 70 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 80 mg or addition of ezetimibe 10 mg to their 40 mg dose of atorvastatin for a 6-week treatment period.
Phase III
First Patient In: 4/6/2006; Last Patient Last Visit 2/26/2008
96 centers worldwide (US, Canada)
Eligible patients include those on a stable dose of atorvastatin 40 mg; or patients with adjusted LDLC
pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin + Ezetemibe | Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks |
| FG001 | Atorvastatin | Atorvastatin 80 mg every day for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin + Ezetemibe | Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks |
| BG001 | Atorvastatin | Atorvastatin 80 mg every day for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C | Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 weeks |
|
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 | Atorvastatin + Ezetemibe | Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
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| atorvastatin |
| Drug |
Atorvastatin 40 mg by mouth, once a day for 6 weeks |
|
| ezetimibe | Drug | Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks. |
|
Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100% |
| Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Total-Cholesterol | Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Triglycerides (TG) | Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) | Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) | Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio | Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio | Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio | Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio | Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks |
| Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) | Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks |
| Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | 6 Weeks |
| Derived |
| Bays H, Conard S, Leiter LA, Bird S, Jensen E, Hanson ME, Shah A, Tershakovec AM. Are post-treatment low-density lipoprotein subclass pattern analyses potentially misleading? Lipids Health Dis. 2010 Nov 30;9:136. doi: 10.1186/1476-511X-9-136. |
| 20151997 | Derived | Conard S, Bays H, Leiter LA, Bird S, Lin J, Hanson ME, Shah A, Tershakovec AM. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab. 2010 Mar;12(3):210-8. doi: 10.1111/j.1463-1326.2009.01152.x. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Could not take time off work |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Apolipoprotein A-I | Mean | Standard Deviation | mg/dL |
|
| Apolipoprotein B | Mean | Standard Deviation | mg/dL |
|
| Apolipoprotein B:Apolipoprotein A-I ratio | Mean | Standard Deviation | Ratio |
|
| C Reactive Protein | Mean | Standard Deviation | mg/dL |
|
| High-Density Lipoprotein | Mean | Standard Deviation | mg/dL |
|
| Low-Density Lipoprotein | Mean | Standard Deviation | mg/dL |
|
| Low-Density Lipoprotein-C:High-Density Lipoprotein-C ratio | Mean | Standard Deviation | Ratio |
|
| Non-High-Density Lipoprotein Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Non-High-Density Lipoprotein-C:High-Density Lipoprotein-C ratio | Mean | Standard Deviation | Ratio |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Total cholesterol:High-Density Lipoprotein-C ratio | Mean | Standard Deviation | Ratio |
|
| Triglycerides | Median | Standard Deviation | mg/dL |
|
Atorvastatin 80 mg every day for 6 weeks
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) | Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) | Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Total-Cholesterol | Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Triglycerides (TG) | Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) | Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) | Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio | Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio | Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio | Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio | Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) | Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100% | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and 6 Weeks |
|
|
|
|
| Secondary | Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Full Analysis Set | Posted | Number | Participants | 6 Weeks |
|
|
|
|
| 9 |
| 63 |
| EG001 | Atorvastatin | Atorvastatin 80 mg every day for 6 weeks | 5 | 61 |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Mental status | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Labile hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase | General disorders | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase | General disorders | MedDRA | Non-systematic Assessment |
|
| Blood bilirubin increased | General disorders | MedDRA | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | General disorders | MedDRA | Non-systematic Assessment |
|
| Blood potassium increased | General disorders | MedDRA | Non-systematic Assessment |
|
| Blood uric acid increased | General disorders | MedDRA | Non-systematic Assessment |
|
| Carotid pulse decreased | General disorders | MedDRA | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | General disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cerebellar ataxia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Cataract operation | General disorders | MedDRA | Non-systematic Assessment |
|
| Inguinal hernia repair | General disorders | MedDRA | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Labile hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009750 |
| Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001384 | Azetidines |
| D001385 | Azetines |