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Completed

NCT Number: NCT00652301

A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

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Key information

Conditions

Cholesterol

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males between the ages of 18-55 with LDL More than 130, but less than 180

Exclusion criteria

  • Individuals with drug or substance abuse
  • Individuals with poor mental function
  • Individuals having more than 14 alcoholic drinks a week
  • Individuals that have been treated with any other investigational drug in the last 30 days

Treatment and study plan

ezetimibe

Drug

ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.

Other names: MK0653

Comparator: Placebo (Unspecified)

Drug

matching placebo tablet. Duration of Treatment 31 Weeks.

simvastatin

Drug

simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

Other names: MK0733

Primary outcomes

  1. reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.

    Time frame: Based on 7 week treatment periods.

Secondary outcomes

  1. To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.

    Time frame: Based on 7 week treatment periods.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

  • Schering-Plough

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Apr 3, 2008
Registry last updated
Aug 15, 2024

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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