Hypercholesterolemia
Conditions
Brief summary
This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.
Interventions
DRUGVytorin (R) (Ezetimibe + Simvastatin)
Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient men or women, age 18 years and above * Patients with primary (heterozygous familial and non-familial) hypercholesterolemia
Exclusion criteria
* Known hypersensitivity to Ezetimibe and Simvastatin * Moderate to severe hepatic insufficiency * Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal * Pregnancy or lactation * Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had an Adverse Event (AE). | Throughout study up to Day 29 (Final Visit) | The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Filipino Patients With Hypercholesterolemia | 4,748 |
| Total | 4,748 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | No Information | 103 |
| Overall Study | Poor Compliance | 16 |
Baseline characteristics
| Characteristic | Filipino Patients With Hypercholesterolemia |
|---|---|
| Age, Continuous | 55.53 years STANDARD_DEVIATION 11.71 |
| Sex: Female, Male Female | 2400 Participants |
| Sex: Female, Male Male | 2348 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,748 |
| serious Total, serious adverse events | 4 / 4,748 |
Outcome results
Primary
Number of Participants Who Had an Adverse Event (AE).
The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.
Time frame: Throughout study up to Day 29 (Final Visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filipino Patients With Hypercholesterolemia | Number of Participants Who Had an Adverse Event (AE). | 62 participants |