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Vytorin As Strategy To Reduce Dislipidemia In Adults

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00651560
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Hyperlipidemia
 Drug: ezetimibe (+) simvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vytorin As Strategy To Reduce Dislipidemia In Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 167
Study Start Date: November 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ezetimibe (+) simvastatin
    ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.
    Other Names:
    • Vytorin®
    • MK0653A
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651560

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00651560     History of Changes
Other Study ID Numbers: 2008_008, MK0653A-148
Study First Received: March 31, 2008
Last Updated: March 31, 2008
Health Authority: Ecuador: Public Health Ministry

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013