NCT00767130

Brief Summary

Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken to lower cholesterol and prevent heart disease. Statins lower cholesterol by different amounts in different patients and sometimes statins cause muscle pain, cramps, or weakness. This study will examine genetic differences in the blood of patients taking statins to predict both how well the statins lower cholesterol, and whether muscle discomfort occurs. Finding such genetic connections is the key to developing genetic tests that might eventually help determine which statin is best for a patient. About 1000 people will be in the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

2.9 years

First QC Date

October 2, 2008

Last Update Submit

October 3, 2008

Conditions

HypercholesterolemiaMyopathy

Keywords

single nucleotide polymorphisms, SNP, LDL cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin

Outcome Measures

Primary Outcomes (2)

  • myopathy

    in response to statin therapy

  • serum creatine kinase activity

    in response to statin therapy

Secondary Outcomes (1)

  • LDL cholesterol

    in response to statin therapy

Study Arms (3)

1

receiving atorvastatin

2

receiving simvastatin

3

receiving rosuvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated for hypercholesterolemia at Hartford Hospital, University of California-San Francisco, or the Rogosin Clinic at New York Presbyterian Hospital

You may qualify if:

  • receiving, or documented to have received in the past, any of the statins including atorvastatin, simvastatin, rosuvastatin treatment for hypercholesterolemia
  • chart-documented clinical record of having had, never having had, or possibly having had, statin-associated myopathy

You may not qualify if:

  • never having taken any statin medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California-San Francisco

San Francisco, California, 94110, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Rogosin Institute, New York Presbyterian Hospital

New York, New York, 10021, United States

RECRUITING

Related Publications (4)

  • Ruano G, Thompson PD, Windemuth A, Seip RL, Dande A, Sorokin A, Kocherla M, Smith A, Holford TR, Wu AH. Physiogenomic association of statin-related myalgia to serotonin receptors. Muscle Nerve. 2007 Sep;36(3):329-35. doi: 10.1002/mus.20871.

    PMID: 17600820BACKGROUND

  • Ruano G, Thompson PD, Windemuth A, Smith A, Kocherla M, Holford TR, Seip R, Wu AH. Physiogenomic analysis links serum creatine kinase activities during statin therapy to vascular smooth muscle homeostasis. Pharmacogenomics. 2005 Dec;6(8):865-72. doi: 10.2217/14622416.6.8.865.

    PMID: 16296949BACKGROUND

  • Ruano G, Seip R, Windemuth A, Wu AH, Thompson PD. Laboratory Medicine in the Clinical Decision Support for Treatment of Hypercholesterolemia: Pharmacogenetics of Statins. Clin Lab Med. 2016 Sep;36(3):473-91. doi: 10.1016/j.cll.2016.05.010. Epub 2016 Jun 24.

    PMID: 27514463DERIVED

  • Ruano G, Windemuth A, Wu AH, Kane JP, Malloy MJ, Pullinger CR, Kocherla M, Bogaard K, Gordon BR, Holford TR, Gupta A, Seip RL, Thompson PD. Mechanisms of statin-induced myalgia assessed by physiogenomic associations. Atherosclerosis. 2011 Oct;218(2):451-6. doi: 10.1016/j.atherosclerosis.2011.07.007. Epub 2011 Jul 20.

    PMID: 21868014DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from blood samples

MeSH Terms

Conditions

HypercholesterolemiaMuscular Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Gualberto Ruano, MD, PhD

    Genomas, Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard L. Seip, PhD

CONTACT

860-545-5005rseip@harthosp.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 6, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

US(3)