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OpenTrials
Completed

NCT Number: NCT00651560

Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid 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

  • Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form.

Exclusion criteria

  • Any Another Kind Of Contraindication For Use Of Statins
  • Hypersensitivity To Any Of The Active Ingredients
  • Increased Serum Hepatic Enzymes (Over 3 Times Only)
  • Patients With Severe Hepatic Insufficiency
  • Women who are Pregnant or Potentially Pregnant

Treatment and study plan

ezetimibe (+) simvastatin

Drug

ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.

Other names: Vytorin®, MK0653A

Primary outcomes

  1. Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals.

    Time frame: After 4 weeks treatment

Secondary outcomes

  1. To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals.

    Time frame: After 4 weeks treatment

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Vytorin As Strategy To Reduce Dislipidemia In Adults

Important dates

Study start
2005
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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