Adults 20 to 80, any sex, with Hypercholesterolemia or Heterozygous Familial Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Experience 1 or More Adverse Event (AE)Primary· up to 54 Weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
82.9
EZ 10 mg/Atorva 20 mg FDC
88.9
Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEsPrimary· up to 54 weeks
Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
30.8
EZ 10 mg/Atorva 20 mg FDC
11.1
Percentage of Participants Who Experience 1 or More Gallbladder-related AEsPrimary· up to 54 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEsPrimary· up to 54 weeks
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, Pruritu
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
6.8
EZ 10 mg/Atorva 20 mg FDC
22.2
Percentage of Participants Who Experience 1 or More Hepatitis-related AEsPrimary· 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)Primary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.9
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants Who Experience Elevations in ALT or AST ≥5 Times ULNPrimary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants Who Experience Elevations in ALT or AST ≥10 Times ULNPrimary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants With Potential Hy's Law ConditionPrimary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULNPrimary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle SymptomsPrimary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle SymptomsPrimary· up to 52 weeks
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.
Group
Value
95% CI
EZ 10 mg/Atorva 10 mg FDC
0.0
EZ 10 mg/Atorva 20 mg FDC
0.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 54 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
EZ10/AT10
Serious: 7/117 (6%)
Deaths: 0/117
EZ10/AT20
Serious: 2/18 (11%)
Deaths: 0/18
Serious adverse events (12 terms)
Reaction
System
EZ10/AT10
EZ10/AT20
Angina pectoris
Cardiac disorders
—
—
Myocardial ischaemia
Cardiac disorders
—
—
Colitis ischaemic
Gastrointestinal disorders
—
—
Inguinal hernia
Gastrointestinal disorders
—
—
Contusion
Injury, poisoning and procedural complications
—
—
Extradural haematoma
Injury, poisoning and procedural complications
—
—
Subdural haematoma
Injury, poisoning and procedural complications
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 16 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02460159.