NCT00241748

Brief Summary

To conduct a case-control study of factors that increased the risk of rhabdomyolysis, an adverse drug reaction in cerivastatin users

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

6.3 years

First QC Date

October 17, 2005

Last Update Submit

January 4, 2012

Conditions

Rhabdomyolysis

Study Arms (3)

1

Rhabdomyolysis Case Subjects

2

Heart and Vascular Health Study statin users - control group 1

3

Cardiovascular Health Study statin users - control group 2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases: persons suffering cervistatin-associated rhabdomyolysis who sued the manufactorer and settled their case Control 1: statin users participating in the Heart and Vascular Health Study Control 2: statin users participating in the Cardiovascular Health Study

You may qualify if:

  • Older than 30 years old

You may not qualify if:

  • Recent history of trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA is extracted from swish and spit samples. DNA is retained.

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Bruce M Psaty, MD, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 19, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

US(1)