Lipid-lowering Therapy Individualization
1 other identifier
interventional
75
1 country
1
Brief Summary
This clinical study will explore individual factors influencing statin pharmacokinetics in a cohort of 150 patients treated with atorvastatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2017
Typical duration for phase_4
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
Study Start
First participant enrolled
August 8, 2017
CompletedFirst Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2019
CompletedSeptember 3, 2019
August 1, 2019
2.1 years
June 27, 2018
August 30, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Atorvastatin population pharmacokinetics
Concentrations of atorvastatin acid (pmol/ml) will be measured by HPLC-MS using sparse samples obtained over the entire study period. Data will be pooled and analyzed using population pharmacokinetic modeling. The reported pharmacokinetic parameters will depend on the type of model that best fits the data.
18 months
Atorvastatin metabolites population pharmacokinetics
Concentrations of ortho-hydroxyatorvastatin (pmol/ml), para-hydroxyatorvastatin (pmol/ml) and atorvastatin lactone (pmol/ml) will be measured by HPLC-MS using sparse samples obtained over the entire study period. Data will be pooled and analyzed using population pharmacokinetic modeling. The reported pharmacokinetic parameters will depend on the type of model that best fits the data.
18 months
Secondary Outcomes (5)
Cholesterol
18 months
Creatine kinase
18 months
Occurrence of adverse drug events
18 months
Pharmacogene genotype
18 months
Triglycerides
18 months
Study Arms (1)
Atorvastatin
OTHERAll patients using atorvastatin at any dose (usually ranging from 5 to 80 mg once-daily).
Interventions
Blood sampling for atorvastatin quantification and pharmacogenetic analysis.
Eligibility Criteria
You may qualify if:
- Treatment with atorvastatin (any dose)
You may not qualify if:
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Luc Balligand, MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 27, 2018
First Posted
July 27, 2018
Study Start
August 8, 2017
Primary Completion
August 27, 2019
Study Completion
August 27, 2019
Last Updated
September 3, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share