Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)
August 12, 2024 updated by: Organon and Co
Vytorin As Strategy To Reduce Dislipidemia In Adults
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
167
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
After 4 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
After 4 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2005
Primary Completion (Actual)
December 23, 2005
Study Completion (Actual)
December 23, 2005
Study Registration Dates
First Submitted
March 31, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimated)
April 3, 2008
Study Record Updates
Last Update Posted (Actual)
August 15, 2024
Last Update Submitted That Met QC Criteria
August 12, 2024
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0653A-148
- MK0653A-148
- 2008_008
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.