SAPhIRE Statin Adverse Drug Reaction

NCT03042286 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2018-10-18

No results posted yet for this study

Summary

To find out the pharmacokinetic and genetic risk factors involved in muscular side effects (myalgia) associated with statin therapy. To learn better ways of identifying risk factors associated with muscle side effects during statin therapy. To perform laboratory analysis to identify factors predicting future outcomes. The genetic material, in combination with other medical information and blood tests, will be available to researchers studying genetic and other factors that contribute to myalgia caused in some patient population on statin medication.

Patients on statin are selected for this study. This study will recruit 1500 subjects from National heart Centre Singapore over a period of 2.5 years.

Participation in the full study includes the donation of genetic material. However, subjects have the option of not having blood subjected to genetic analysis and still participate in the study. In this case, blood samples will only be analyzed for the statin drug content.

Conditions

  • Myopathy

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER
  • National Heart Centre Singapore

    lead OTHER

Principal Investigators

  • Dr Wei Chieh Jack Tan · National Heart Centre Singapore

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042286 on ClinicalTrials.gov