Functional and Clinical Impact of CYP3A Genetic Polymorphisms on Statin Therapy

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01867203
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 0

Study Details

Study Description

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	Phase
Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy	Other: Genotyping

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Lipid-lowering Therapy Individualization
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Statin users	Other: Genotyping; DNA extraction from blood

Outcome Measures

Primary Outcome Measures

1. Cholesterol levels-side effects [1 to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient known to be compliant

• Age [25-80]

• treated with Atorvastatin, simvastatin, fluvastatin.

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint-Luc Hospital	Brussels		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT01867203
• Other Study ID Numbers: CYPstatin001
• First Posted: Jun 3, 2013
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

No Results Posted as of Mar 18, 2021