Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
- Conditions
- Homozygous Familial HypercholesterolemiaPrimary Hypercholesterolemia
- Interventions
- Registration Number
- NCT00704535
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4105
- Outpatient men or women, age 18 years and above.
- Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.
- Known hypersensitivity to Ezetimibe.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with hypercholesterolemia Ezetimibe Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin
- Primary Outcome Measures
Name Time Method Safety as Measured by Number of Subjects With at Least One Adverse Event 28 days after Visit 1 Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event 28 days after Visit 1 To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event
Safety as Measured by Outcome of Adverse Events 28 days after Visit 1 To evaluate overall safety of ezetimibe as measured by outcome of adverse events
Tolerability as Measured by Subject Self-assessment 28 days after Visit 1 Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. 28 days after Visit 1 To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.
Safety as Measured by Number and Type of Adverse Events. 28 days after Visit 1 Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.
Safety as Measured by Severity of Adverse Events as Determined by the Investigator 28 days after Visit 1 To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator
- Secondary Outcome Measures
Name Time Method To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) 28 days after Visit 1 Change in mean total cholesterol values