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WithdrawnNCT01569854Updated Sep 27, 2016

Genetic Influence on Statin Pharmacodynamics

An observational study in Hyperlipidemia, Hypercholesterolemia and Dyslipidemia, sponsored by Ohio State University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by Ohio State University · Observational

Why this study was withdrawn
Insufficient recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hyperlipidemia
  • Hypercholesterolemia
  • Dyslipidemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

Browse Hypercholesterolemia studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • statin
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

07

Study locations

1 site
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01569854
Lead sponsor
Ohio State University
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Joseph Kitzmiller (Assistant Professor, Ohio State University) — Principal investigator
First posted
Apr 3, 2012
Start date
Mar 2012
Primary completion
Mar 2016 (estimated)
Completion
Mar 2022 (estimated)
Last update
Sep 27, 2016

Study contacts

Joseph P Kitzmiller, MD PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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