Vascular and Metabolic Effects of Vytorin vs Simvastatin

• Sponsor: Gachon University Gil Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01666067
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 17

Study Details

Study Description

Brief Summary

The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: placebo; Drug: vytorin; Drug: simvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: placebo placebo	Drug: placebo
Active Comparator: vytorin vytorin	Drug: vytorin
Active Comparator: simvastatin simvastatin	Drug: simvastatin

Outcome Measures

Primary Outcome Measures

1. flow-mediated dilation [8 weeks of treatment]

Secondary Outcome Measures

1. insulin resistance [8 weeks of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• hypercholesterolemic patients (LDL cholesterol levels>100 mg/dl)

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

Locations

	Site	City	State	Country	Postal Code
1	Gil Medical Center	Incheon		Korea, Republic of	405-760

Sponsors and Collaborators

• Gachon University Gil Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kwang Kon Koh, professor, Gachon University Gil Medical Center
• ClinicalTrials.gov Identifier: NCT01666067
• Other Study ID Numbers: GMC-201110
• First Posted: Aug 16, 2012
• Last Update Posted: Nov 4, 2014
• Last Verified: Aug 1, 2012

• Keywords provided by Kwang Kon Koh, professor, Gachon University Gil Medical Center: insulin resistance
• Additional relevant MeSH terms: Hypercholesterolemia; Simvastatin; Ezetimibe, Simvastatin Drug Combination

Study Results

No Results Posted as of Nov 4, 2014