Patients With High Cholesterol Levels Needing a Lipid-lowering TherapyNCT01867203
Functional and Clinical Impact of CYP3A Genetic Polymorphisms on Statin Therapy
An observational study of Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy
- What is being tested?
- Genotyping
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2017to 1 Sep 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with statin drugs
Who may be able to join
- Patient known to be compliant
- Age [25-80]
- treated with Atorvastatin, simvastatin, fluvastatin.
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid-lowering Therapy Individualization
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.
- Being tested
- Genotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingOther
DNA extraction from blood
| Study group | Role | What they receive |
|---|---|---|
| Statin users | Not described Receives: Other: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol levels-side effects
Measured: 1 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study start1 Aug 2017
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With High Cholesterol Levels Needing a Lipid-lowering TherapyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867203
- Sponsor's protocol ID
- CYPstatin001
- Status last verified
- Mar 2021
- First submitted
- 29 May 2013
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid-lowering Therapy Individualization
- ClinicalTrials.gov ID
- NCT01867203
- Acronym / sponsor ID
- CYPstatin001
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Statin users | – | Other: Genotyping |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with statin drugs
Key inclusion criteria (3 listed)
- Patient known to be compliant
- Age [25-80]
- treated with Atorvastatin, simvastatin, fluvastatin.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotypingDNA extraction from blood | Other | Statin users |
Primary outcome
Cholesterol levels-side effects
Time frame: 1 to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With High Cholesterol Levels Needing a Lipid-lowering Therapy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol levels-side effects (time frame: 1 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.