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Completed

NCT Number: NCT00704535

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe

Drug

1 tablet of 10 mg once daily

Other names: SCH 58235

Primary outcomes

  1. Safety as Measured by Number of Subjects With at Least One Adverse Event

    Time frame: 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

  2. Safety as Measured by Number and Type of Adverse Events.

    Time frame: 28 days after Visit 1

    Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.

  3. Safety as Measured by Severity of Adverse Events as Determined by the Investigator

    Time frame: 28 days after Visit 1

    To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator

  4. Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.

    Time frame: 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.

  5. Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event

    Time frame: 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

  6. Safety as Measured by Outcome of Adverse Events

    Time frame: 28 days after Visit 1

    To evaluate overall safety of ezetimibe as measured by outcome of adverse events

  7. Tolerability as Measured by Subject Self-assessment

    Time frame: 28 days after Visit 1

    Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment

Secondary outcomes

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

    Time frame: 28 days after Visit 1

    Change in mean total cholesterol values

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 25, 2008
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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