NCT01867203

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
4.2 years until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

May 29, 2013

Last Update Submit

March 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cholesterol levels-side effects

    1 to 6 months

Study Arms (1)

Statin users

Other: Genotyping

Interventions

DNA extraction from blood

Statin users

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Interventions

Genotype

Intervention Hierarchy (Ancestors)

Genetic Phenomena
0

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

Locations