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NCT01569854 Clinical Trial

Genetic Influence on Statin Pharmacodynamics

Hypercholesterolemia Clinical Trial

Official title:
An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01569854
Other study ID # OSU 2011H0261
Secondary ID K23GM100372
Status Withdrawn
Phase N/A
First received March 30, 2012
Last updated September 26, 2016
Start date March 2012
Est. completion date March 2022

Study information
Verified date September 2016
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 2022
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin

Exclusion Criteria:

- concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary carotid intimal media thickness (CIMT) CIMT measurements will be performed at baseline (within 3 months of starting statin) and at 6, 12, 18, and 24 months. Change in CIMT is considered a surogate measure of atherosclerotic progression. 2 years No
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