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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT00704535
• Date of registration: 23/06/2008
• Prospective Registration: No
• Primary sponsor: Organon and Co
• Public title: Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
• Scientific title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients
• Date of first enrolment: March 2006
• Target sample size: 4105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00704535
• Study type: Observational

Countries of recruitment

Philippines

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Homozygous Familial Hypercholesterolemia

Primary Hypercholesterolemia

Intervention(s)

Drug: Ezetimibe

Primary Outcome(s)

Safety as Measured by Number of Subjects With at Least One Adverse Event [Time Frame: 28 days after Visit 1]

Safety as Measured by Severity of Adverse Events as Determined by the Investigator [Time Frame: 28 days after Visit 1]

Tolerability as Measured by Subject Self-assessment [Time Frame: 28 days after Visit 1]

Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. [Time Frame: 28 days after Visit 1]

Safety as Measured by Outcome of Adverse Events [Time Frame: 28 days after Visit 1]

Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event [Time Frame: 28 days after Visit 1]

Safety as Measured by Number and Type of Adverse Events. [Time Frame: 28 days after Visit 1]

Secondary Outcome(s)

To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) [Time Frame: 28 days after Visit 1]

Secondary ID(s)

P04748

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/07/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00704535