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Completed

NCT Number: NCT00389896

A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)

The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.

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Key information

Conditions

HDL Cholesterol

Age range

18 year–75 year

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

  • Patient has stable Type 2 diabetes mellitus at Visit 1.
  • Patient meets screening criteria based on Visit 1 lab tests

Exclusion criteria

  • Patient is pregnant, breastfeeding, or at risk of becoming pregnant
  • Patient has heart disease, uncontrolled high blood pressure, or other significant disease
  • Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study

Treatment and study plan

MK0733 / Duration of Treatment: 18 Weeks

Drug

Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks

Drug

Primary outcomes

  1. HDL-C raising effects after 6 weeks

    Time frame: 6 weeks

Secondary outcomes

  1. Effect on other lipids and lipoproteins at 6 weeks

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Oct 19, 2006
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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