Vascular and Metabolic Effects of Rosuvastatin

This study is currently recruiting participants.
Verified August 2012 by Gachon University Gil Medical Center
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01660919
First received: August 8, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.


Condition Intervention Phase
Hypercholesterolemia
Drug: placebo
Drug: rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo
Drug: placebo
Active Comparator: rosuvastatin 5
rosuvastatin 5 mg
Drug: rosuvastatin
Active Comparator: rosuvastatin 10
rosuvastatin 10 mg
Drug: rosuvastatin
Active Comparator: rosuvastatin 20
rosuvastatin 20 mg
Drug: rosuvastatin

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660919

Contacts
Contact: Kwang K Koh, MD,PhD 82-32-460-3683 kwangk@gilhospital.com

Locations
Korea, Republic of
Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Seung H Han, MD    82-32-460-3650    shhan@gilhospital.com   
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01660919     History of Changes
Other Study ID Numbers: GMC-201105
Study First Received: August 8, 2012
Last Updated: August 8, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
insulin resistance

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

ClinicalTrials.gov processed this record on April 17, 2014