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

NCT00704535 | Completed Results

• 1 other identifier: P04748
• Study Type: observational
• Target: 4,105
• Locations: 0 countries
• Sites: N/A

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

Conditions

Primary Hypercholesterolemia; Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)

  28 days after Visit 1

Study Arms (1)

Subjects with hypercholesterolemia

Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin

Drug: Ezetimibe

Interventions

Ezetimibe DRUG

1 tablet of 10 mg once daily

Also known as: SCH 58235

Subjects with hypercholesterolemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Filipino subjects with hypercholesterolemia

You may qualify if:

• Outpatient men or women, age 18 years and above.
• Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type II; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 9, 2022
• Results First Posted: July 14, 2009

Record last verified: 2022-02