Vascular and Metabolic Effects of Rosuvastatin

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014