Genetic Influences on Statin Blood Concentrations in Afri... | NCT01569867

Studies
Genetic Influences on Statin Blood Concentrations in African Americans

NCT01569867

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Oct 13, 2022Actual

Enrollment

501Actual

Phase

Not provided

Conditions

Hyperlipidemia
Hypercholesterolemia
Dyslipidemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K23GM100372	U.S. NIH Grant/Contract		View source
R01MD011307	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012Actual

Primary Completion Date

Jan 2022Actual

Completion Date

Apr 20, 2022Actual

First Submitted Date

Mar 30, 2012

First Submission Date that Met QC Criteria

Mar 30, 2012

First Posted Date

Apr 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2022

Last Update Posted Date

Oct 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sakima Smith, Associate Professor, Ohio State UniversityPrincipal Investigator

Lead Sponsor

Ohio State UniversityOTHER

Collaborators

Name	Class
National Institute of General Medical Sciences (NIGMS)	NIH
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in African-American patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

501Actual

Label	Type	Description	Intervention Names
statin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-hour area under the time-concentration curve of statin concentrations in plasma		2 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of statin-associated muscle symptoms (SAMS)		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin)

Exclusion Criteria:

Age less than 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph P Kitzmiller, MD PhD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Medical Center		Columbus	Ohio	43210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25612772	Background	Wang J, Luzum JA, Phelps MA, Kitzmiller JP. Liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of simvastatin, lovastatin, atorvastatin, and their major metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Mar 1;983-984:18-25. doi: 10.1016/j.jchromb.2014.12.029. Epub 2015 Jan 13.

ID	Term
D006949	Hyperlipidemias
D006937	Hypercholesterolemia
D050171	Dyslipidemias

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases