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Functional and Clinical Impact of CYP3A Genetic Polymorphisms on Statin Therapy

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ClinicalTrials.gov Identifier: NCT01867203
Recruitment Status : Recruiting
First Posted : June 3, 2013
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment
Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy Other: Genotyping

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Lipid-lowering Therapy Individualization
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Statin users Other: Genotyping
DNA extraction from blood




Primary Outcome Measures :
  1. Cholesterol levels-side effects [ Time Frame: 1 to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with statin drugs
Criteria

Inclusion Criteria:

  • Patient known to be compliant
  • Age [25-80]
  • treated with Atorvastatin, simvastatin, fluvastatin.

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867203


Contacts
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Contact: Laure Elens, PhD +32 764 5351 laure.elens@uclouvain.be

Locations
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Belgium
Saint-Luc Hospital Recruiting
Brussels, Belgium, 1200
Contact: Haufroid Vincent, PhD         
Principal Investigator: Laure Elens, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Additional Information:

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01867203     History of Changes
Other Study ID Numbers: CYPstatin001
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases