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| ID | Type | Description | Link |
|---|---|---|---|
| 152982 | Registry Identifier | JAPIC |
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This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZ 10 mg/Atorva 10 mg FDC | Experimental | one EZ 10 mg/Atorva 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks. |
|
| EZ 10 mg/Atorva 20 mg FDC | Experimental | one EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZ 10 mg/Atorva 20 mg FDC | Drug |
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| |
| EZ 10 mg/Atorva 10 mg FDC |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience 1 or More Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. | up to 54 Weeks |
| Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs | Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache. | up to 54 weeks |
| Percentage of Participants Who Experience 1 or More Gallbladder-related AEs | Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis. | up to 54 weeks |
| Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs | Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Teramoto T, Yokote K, Nishida C, Tershakovec A, Oshima N, Takase T, Hirano T. A Phase III open-label clinical trial to assess the long-term safety of ezetimibe and atorvastatin combination therapy in Japanese patients with hypercholesterolemia. J Clin Therapeut Med. 2017;33(8):655-670. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EZ 10 mg/Atorva 10 mg FDC | One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks. |
| FG001 | EZ 10 mg/Atorva 20 mg FDC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| up to 54 weeks |
| Percentage of Participants Who Experience 1 or More Hepatitis-related AEs | Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic. | up to 54 weeks |
| Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) | Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | up to 52 weeks |
| Percentage of Participants Who Experience Elevations in ALT or AST ≥5 Times ULN | Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT or AST that were 5x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | up to 52 weeks |
| Percentage of Participants Who Experience Elevations in ALT or AST ≥10 Times ULN | Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | up to 52 weeks |
| Percentage of Participants With Potential Hy's Law Condition | Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL. | up to 52 weeks |
| Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN | Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | up to 52 weeks |
| Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms | Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | up to 52 weeks |
| Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms | Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | up to 52 weeks |
One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EZ 10 mg/Atorva 10 mg FDC | One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks. |
| BG001 | EZ 10 mg/Atorva 20 mg FDC | One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants Who Experience 1 or More Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 54 Weeks |
|
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| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs | Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of participants | up to 54 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience 1 or More Gallbladder-related AEs | Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis. | All participants that received at least 1 dose of study drug and had available data for outcome. | Posted | Number | Percentage of Participants | up to 54 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs | Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 54 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience 1 or More Hepatitis-related AEs | Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 54 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) | Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience Elevations in ALT or AST ≥5 Times ULN | Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT or AST that were 5x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience Elevations in ALT or AST ≥10 Times ULN | Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potential Hy's Law Condition | Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN | Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms | Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms | Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | All participants that received at least 1 dose of study drug and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 52 weeks |
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Up to 54 weeks
Population included all participants that received at least 1 dose of study drug.
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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 | EZ10/AT10 | One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks. | 0 | 117 | 7 | 117 | 77 | 117 |
| EG001 | EZ10/AT20 | One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks. | 0 | 18 | 2 | 18 | 16 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Progressive supranuclear palsy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Scintillating scotoma | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oral hyperaesthesia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Periodontal disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Hepatic cyst | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Electrocardiogram ST-T segment depression | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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