Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

Primary Hypercholesterolemia Clinical Trial

Official title:

Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704535
• Other study ID #: P04748
• Status: Completed
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4105
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatient men or women, age 18 years and above.

• Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Homozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II
• Primary Hypercholesterolemia

Intervention

Drug:
• Ezetimibe
1 tablet of 10 mg once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as Measured by Number of Subjects With at Least One Adverse Event	Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event	28 days after Visit 1
Primary	Safety as Measured by Number and Type of Adverse Events.	Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.	28 days after Visit 1
Primary	Safety as Measured by Severity of Adverse Events as Determined by the Investigator	To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator	28 days after Visit 1
Primary	Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.	To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.	28 days after Visit 1
Primary	Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event	To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event	28 days after Visit 1
Primary	Safety as Measured by Outcome of Adverse Events	To evaluate overall safety of ezetimibe as measured by outcome of adverse events	28 days after Visit 1
Primary	Tolerability as Measured by Subject Self-assessment	Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment	28 days after Visit 1
Secondary	To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)	Change in mean total cholesterol values	28 days after Visit 1