ObesityPhase 3NCT01768481
Intima Media Thickness Regression in Dyslipidemic Teenagers
A Phase 3 study testing Atorvastatin and sugar pill in people with Obesity and Dyslipidemia, run by Université de Montréal at 1 site in Canada.
Trial summary
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dyslipidemia
- What is being tested?
- Atorvastatin and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Jun 2010
- Phase
- Phase 3
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obesity
- Abnormal Triglyceride levels (>1.7mmol/L).
- Abnormal HDL-C levels (1.0mmol/L)
Who cannot join
- Abnormal thyroid unfction (not treated)
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.
Read the detailed description
Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.
- Conditions
- Obesity, Dyslipidemia
- Being tested
- Atorvastatin, sugar pill
- Keywords
- Obesity, Dyslipidemia, Cholesterol, Intima media thickness
- Medical subject headings
- Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Statin, Lipitor
10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
sugar pillDrug
Also called placebo
placebo controlled arm receives similarly looking placebo.
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | Atorvastatin 10 mg every day for one year Receives: Drug: Atorvastatin |
| Sugar pill | Placebo comparator | Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year. Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima media thickness
Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)
Measured: 12 months
Secondary outcomes (1)
weight
weight, height and BMI recorded before and after intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2004
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Laurent Legault, Université de Montréal
- Investigators
- Laurent Legault, MD, Principal investigator, Hopital Maisonneuve-Rosemont, UMontreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768481
- Sponsor's protocol ID
- HMR
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
- ClinicalTrials.gov ID
- NCT01768481
- Acronym / sponsor ID
- HMR
- Conditions
- Obesity, Dyslipidemia
- Keywords
- Obesity, Dyslipidemia, Cholesterol, Intima media thickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Jan 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.
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.
Detailed description
Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: AtorvastatinAtorvastatin 10 mg every day for one year |
| Sugar pill | Placebo comparator | Drug: sugar pillSame size, taste and size placebo tablet (manufactured by sponsor) given every day for one year. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Obesity
- Abnormal Triglyceride levels (>1.7mmol/L).
- Abnormal HDL-C levels (1.0mmol/L)
Key exclusion criteria (2 listed)
- Abnormal thyroid unfction (not treated)
- Diabetes
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 |
|---|---|---|
| AtorvastatinAlso: Statin, Lipitor10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year | Drug | Statin |
| sugar pillAlso: placeboplacebo controlled arm receives similarly looking placebo. | Drug | Sugar pill |
Primary outcome
carotid intima media thickness
Time frame: 12 months
Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)
1 secondary outcome
weight
Time frame: 12 months
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 15 Jan 2013.
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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.
Laurent Legault, MD principal investigator
Hopital Maisonneuve-Rosemont, UMontreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin and sugar pill in people with Obesity and Dyslipidemia, run by Université de Montréal 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 3 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 15 Jan 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
carotid intima media thickness (time frame: 12 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 15 Jan 2013.