Study Stopped
No patients enrolled
Functional and Clinical Impact of CYP3A Genetic Polymorphisms on Statin Therapy
Lipid-lowering Therapy Individualization
1 other identifier
observational
N/A
1 country
1
Brief Summary
Patients needing lipid lowering therapy will be recruited before initiation of the treatment. For each patient, total and LDL cholesterol levels before start of therapy will be measured. One, three and six months after his/her first visit, when steady-state will be reached, for each included patient, the cholesterol levels will be re-assessed in order to evaluate the response to statin therapy calculated as the amplitude of cholesterol reduction. The aim is to assess the association between patient's genotype and the response to statin therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
June 3, 2013
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 18, 2021
March 1, 2021
2 years
May 29, 2013
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Cholesterol levels-side effects
1 to 6 months
Study Arms (1)
Statin users
Interventions
Eligibility Criteria
Patients treated with statin drugs
You may qualify if:
- Patient known to be compliant
- Age \[25-80\]
- treated with Atorvastatin, simvastatin, fluvastatin.
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint-Luc Hospital
Brussels, 1200, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2013
First Posted
June 3, 2013
Study Start
August 1, 2017
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
March 18, 2021
Record last verified: 2021-03