AtherosclerosisNCT00847782
An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism
A study testing Blood draw in people with Atherosclerosis, run by Bristol-Myers Squibb at 1 site in Canada.
Trial summary
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Sep 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypercholesterolemia
- Statin monotherapy
Who cannot join
- Significant acute or chronic illness
- Secondary causes of hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels
- Conditions
- Atherosclerosis
- Being tested
- Blood draw
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
1 day
| Study group | Role | What they receive |
|---|---|---|
| Blood draw (Group 1) | Other | Normocholesterolemic Subjects
Normal Healthy Volunteers Receives: Procedure: Blood draw |
| Blood draw (Group 2) | Other | Hypercholesterolemic Subjects Receives: Procedure: Blood draw |
| Blood draw (Group 3) | Other | Hypercholesterolemic Subjects with Statin Treatment Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PCSK9 concentration
Measured: Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled
Secondary outcomes (4)
Serum LDL cholesterol concentration
Measured: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum HDL cholesterol concentration
Measured: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum TG concentration
Measured: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum Apo B concentration
Measured: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847782
- Sponsor's protocol ID
- CV198-001
- Status last verified
- Nov 2009
- First submitted
- 6 Feb 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT00847782
- Acronym / sponsor ID
- CV198-001
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Feb 2009 (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.
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood draw (Group 1) | Other | Procedure: Blood drawNormocholesterolemic Subjects Normal Healthy Volunteers |
| Blood draw (Group 2) | Other | Procedure: Blood drawHypercholesterolemic Subjects |
| Blood draw (Group 3) | Other | Procedure: Blood drawHypercholesterolemic Subjects with Statin Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypercholesterolemia
- Statin monotherapy
Key exclusion criteria (2 listed)
- Significant acute or chronic illness
- Secondary causes of hypercholesterolemia
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 |
|---|---|---|
| Blood draw1 day | Procedure or surgery | Blood draw (Group 1), Blood draw (Group 2), Blood draw (Group 3) |
Primary outcome
Serum PCSK9 concentration
Time frame: Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled
4 secondary outcomes
Serum LDL cholesterol concentration
Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum HDL cholesterol concentration
Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum TG concentration
Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum Apo B concentration
Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2009.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw in people with Atherosclerosis, run by Bristol-Myers Squibb at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 2009. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum PCSK9 concentration (time frame: Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled). 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 5 Nov 2009.