Hypercholesterolemia
Conditions
Brief summary
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.
Interventions
DRUGEzetimibe
Ezetimibe 10 mg once daily
DRUGSimvastatin
Simvastatin 20 mg daily
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with hypercholesterolemia who satisfy the following criteria: * Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as statins) for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below * Age: 20 years of age or older (at the time of obtaining informed consent) * Sex: both males and females * Inpatient/outpatient: Out-patients
Exclusion criteria
* Patients for whom any of the following is applicable: * Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL * Patients with homozygous familial hypercholesterolemia * Patients with creatine phosphokinase (CPK) \> 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period. * Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x ULN measured at the start of the observation period or the treatment period. * Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets * Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study. * Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.) * Patients who are using cyclosporine from after the start of the observation period * Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate * Patients with a history of ezetimibe use * Patients with hyperlipidemia associated with the following diseases: * Hypothyroidism * Obstructive gall bladder or biliary disease * Chronic renal failure * Pancreatitis * Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc * Patients who have received an investigational drug within 4 weeks of the start of the observation period * Other patients deemed not appropriate for study entry by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Reactions | Throughout 1 year of study | An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was treatment-related was considered an adverse reaction. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe + Simvastatin Ezetimibe 10 mg + Simvastatin 20 mg | 151 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Adverse reaction did not improve (4) | 1 |
| Overall Study | Drop in low density lipoprotein (1) | 2 |
| Overall Study | Elevated alanine aminotransferase (3) | 2 |
| Overall Study | Elevated creatine phosphokinase (2) | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Ezetimibe + Simvastatin |
|---|---|
| Age, Customized | 151 Participants |
| Region of Enrollment Japan | 151 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 127 / 151 |
| serious Total, serious adverse events | 17 / 151 |
Outcome results
Primary
Number of Participants With Adverse Events and Adverse Reactions
An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was treatment-related was considered an adverse reaction.
Time frame: Throughout 1 year of study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ezetimibe + Simvastatin | Number of Participants With Adverse Events and Adverse Reactions | Adverse Events | 143 Participants |
| Ezetimibe + Simvastatin | Number of Participants With Adverse Events and Adverse Reactions | Adverse Reactions | 36 Participants |