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OpenTrials
Completed

NCT Number: NCT00651963

Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)

Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.

Completed

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Key information

Conditions

Lipid Metabolism Disorder Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years old
  • Lipid Metabolic Disorder as Per ATP III who have not reached the goals and who are on statins for at least 4 weeks Or those who require LDL reductions Over 50% to reach the ATP III goals or who need statins in accordance their risk score

Exclusion criteria

  • Pregnancy, Breast Feeding
  • Moderate/Sever Liver Disease: Child Score > Or = To 7
  • Fibrates Terminal Disease
  • Contraindications To Receive ezetimibe
  • Contraindications To Receive Statins
  • Mental Disability
  • Hypersensitivity To ezetimibe
  • On another Clinical Research Trial

Treatment and study plan

ezetimibe

Drug

Ezetimibe 10 mg daily was added during 4 weeks.

The patients continued taking their usual Statin without titrating the dose.

Other names: Zetia®, MK0653

Primary outcomes

  1. Lipid profile

    Time frame: Over 8 Weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
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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