Vascular and Metabolic Effects of Vytorin

November 1, 2014 updated by: Kwang Kon Koh, Gachon University Gil Medical Center
The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hypercholesterolemia

Exclusion Criteria:

  • overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo
ACTIVE_COMPARATOR: vytorin 10
vytorin 10 mg
Drug: vytorin
ACTIVE_COMPARATOR: vytorin 20
vytorin 20 mg
Drug: vytorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
flow-mediated dilation
Time Frame: 8 weeks of treatment
8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
insulin resistance
Time Frame: 8 weeks of treatment
8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

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

July 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (ESTIMATE)

August 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 1, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMC-201102

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.

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