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Vascular and Metabolic Effects of Rosuvastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660919
First Posted: August 9, 2012
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kwang Kon Koh, Gachon University Gil Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kwang Kon Koh, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ]

Estimated Enrollment: 160
Study Start Date: October 2011
Study Completion Date: December 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660919


Locations
Korea, Republic of
Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Responsible Party: Kwang Kon Koh, professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01660919     History of Changes
Other Study ID Numbers: GMC-201105
First Submitted: August 8, 2012
First Posted: August 9, 2012
Last Update Posted: November 4, 2014
Last Verified: August 2012

Keywords provided by Kwang Kon Koh, Gachon University Gil Medical Center:
insulin resistance

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