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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00651560
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: ezetimibe (+) simvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vytorin As Strategy To Reduce Dislipidemia In Adults
Actual Study Start Date : November 1, 2005
Actual Primary Completion Date : December 23, 2005
Actual Study Completion Date : December 23, 2005

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: ezetimibe (+) simvastatin
    ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.
    Other Names:
    • Vytorin®
    • MK0653A

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00651560

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Study Data/Documents: CSR Synopsis Links  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00651560     History of Changes
Other Study ID Numbers: 0653A-148
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors