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OpenTrials
Completed

NCT Number: NCT00541697

Eze/Simva Switch Study in Diabetics (0653A-807)

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Currently being treated with Atorvastatin 10 mg for at least 6 weeks
  • Have Type 2 Diabetes
  • Weight must be stable for more than 6 weeks before entering the study

Exclusion criteria

  • Consume more than 14 alcoholic drinks per week.
  • Pregnant or lactating
  • Have taken another investigation drug within 3 months of starting this study
  • History of congestive heart failure, heart attack, coronary artery bypass surgery
  • Uncontrolled high blood pressure
  • HIV positive
  • History of cancer in the last 5 years

Treatment and study plan

MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks

Drug

Comparator: atorvastatin / Duration of Treatment: 6 Weeks

Drug

Primary outcomes

  1. Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment

    Time frame: 6 Weeks

Secondary outcomes

  1. Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment

    Time frame: 6 Weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Oct 10, 2007
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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