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| ID | Type | Description | Link |
|---|---|---|---|
| 163336 | Registry Identifier | JAPIC-CTI |
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This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (LDL-C) after 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe 10 mg | Active Comparator | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks |
|
| Rosuvastatin 2.5 mg | Active Comparator | 1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks. |
|
| Rosuvastatin 5.0 mg | Active Comparator | 2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks. |
|
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | Experimental | 1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks. |
|
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | Experimental | 1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe 10 mg | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) | Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate. | Baseline and Week 12 |
| Percentage of Participants Who Experience at Least 1 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 14 weeks |
| Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event | 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 had study drug discontinued due to an AE was summarized. | up to 12 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 14 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Teramoto T, Yokote K, Nishida C, Oshima N, Takase T. A phase III clinical trial to study the efficacy and safety of ezetimibe plus rosuvastatin combination therapy in Japanese patients with hypercholesterolemia - A randomized, double-blind comparative study. J Clin Therapeut Med. 2017;33(11):881-896. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe 10 mg | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks |
| FG001 | Rosuvastatin 2.5 mg | 1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks. |
| FG002 | Rosuvastatin 5.0 mg | 2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks. |
| FG003 | Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks. |
| FG004 | Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe 10 mg | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks |
| BG001 | Rosuvastatin 2.5 mg | 1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 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 | Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) | Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate. | All randomized participants who received at least 1 dose of study drug, had baseline or post-baseline data and had baseline data for those analyses that required baseline data. | Posted | Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
|
up to 2 weeks post last dose of study drug (up to 14 weeks total)
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 | Ezetimibe 10 mg | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial prostatitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2016 | Feb 9, 2018 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Rosuvastatin 2.5 mg |
| Drug |
|
| Placebo for Ezetimibe | Drug |
|
| Placebo for Rosuvastatin | Drug |
|
| up to 14 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. | up to 14 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 14 weeks |
| Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L. | up to 12 weeks |
| Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.. | up to 12 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 12 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 12 weeks |
| Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L. | up to 12 weeks |
| Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN) | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 5x ULN or greater were recorded. The AST ULN was 40 U/L. | up to 12 weeks |
| Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L. | up to 12 weeks |
| Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN) | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 10x ULN or greater were recorded. The AST ULN was 40 U/L. | up to 12 weeks |
| Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN) | Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive 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 12 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 alkalinephosphatase <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 12 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 12 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 12 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 12 weeks |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Rosuvastatin 5.0 mg | 2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks. |
| BG003 | Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks. |
| BG004 | Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
| OG002 | Rosuvastatin 5.0 mg | 2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks. |
| OG003 | Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks. |
| OG004 | Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks. |
|
|
|
| Primary | Percentage of Participants Who Experience at Least 1 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
| Primary | Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event | 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 had study drug discontinued due to an AE was summarized. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of participants | up to 12 weeks |
|
|
|
| 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 14 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
| 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 14 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| 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 12 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN) | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 5x ULN or greater were recorded. The AST ULN was 40 U/L. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN) | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 10x ULN or greater were recorded. The AST ULN was 40 U/L. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN) | Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| 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 alkalinephosphatase <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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 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 randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 6 |
| 35 |
| EG001 | Rosuvastatin 2.5 mg | 1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks. | 0 | 72 | 0 | 72 | 8 | 72 |
| EG002 | Rosuvastatin 5.0 mg | 2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks. | 0 | 71 | 1 | 71 | 11 | 71 |
| EG003 | Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks. | 0 | 71 | 0 | 71 | 6 | 71 |
| EG004 | Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks. | 0 | 72 | 0 | 72 | 7 | 72 |
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.
| D009750 |
| Nutritional and Metabolic Diseases |
| D013449 |
| Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |