Endothelial FunctionNCT01241097
Pleiotropism of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe
A study of Endothelial Function, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
To test the hypothesis that therapy with high dose statin provides endothelial superior benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe. To test the hypothesis that therapy with high dose statin provides anti-inflammatory effect than the same reduction of cholesterol with low dose… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Dec 2011
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with body mass index (BMI)> 25 kg / m²
- Aged > 18 years
- LDL-C> 100 mg / dl
Who cannot join
- Previous use of statins, fibrates or ezetimibe
- Triglycerides> 400 mg / dl
- Serum creatinine greater than 2.0 md / dl
- Elevated liver enzymes, more than one and half times the upper limit of normal
- Creatine kinase (CK) levels more than three times the upper limit of normal
- Pregnant
Show all 12Show fewer
- Breast-feeding
- Heart failure
- Psychiatric disorders
- Hormone replacement therapy.
- The occurrence of recent onset within the last four weeks of treatment with beta-blockers, converting enzyme inhibitor or calcium channel blocker, the intervention should be undertaken after a period of at least four weeks of continuous use.
- Acute inflammatory processes in the last month, assessed by clinical history and physical examination (ear, throat, skin lesions or other inflammatory manifestations) as well as reports of chronic diseases such as collagen, or the occurrence of active tuberculosis in the last three months will be excluded from work.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Escola Bahiana de Medicina e Saúde Púiblica
Salvador, Estado de Bahia, 40000
Marilia G Rodrigues, MD, 55-71-3359485, mgaleffi@cardiol.br
Paulo Roberto P Lima, student, 55-71-99184765, prpassoslima@hotmail.com
About this study
Official title: Comparison of the Effect on Endothelial Function of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe
- To test the hypothesis that therapy with high dose statin provides endothelial superior benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.
- To test the hypothesis that therapy with high dose statin provides anti-inflammatory effect than the same reduction of cholesterol with low dose of statin plus ezetimibe
Read the detailed description
Randomized, double-blind, placebo-controlled study. Inclusion Criteria: Obese women with body mass index (BMI)> 25 kg / m², aged 18 years and LDL-C> 100 mg / dl For treatment with simvastatin 80 mg, the participant will receive two identical vials, each containing a simvastatin 40 mg. For treatment with the combination simvastatin 10 mg and ezetimibe 10 mg, the participant will receive two identical bottles, one bottle with simvastatin 10 mg, and another bottle with ezetimibe 10mg. In the control group, each participant will receive two identical bottles, each bottle containing inert tablets. Each group with 20 participants.
Dependent Variable (Final Primary Outcome): Percentage change vasodilation of brachial artery flow-mediated, after treatment for eight weeks.
Covariates: clinical, biochemical markers and ultrasound.
- Conditions
- Endothelial Function
- Being tested
- simvastatin, combined with simvastatin ezetimibe, placebo
- Keywords
- endothelial function, statins, ezetimibe, pleiotropism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatin, combined with simvastatin ezetimibe, placeboDrug
Also called zocor, vytorin
simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo
| Study group | Role | What they receive |
|---|---|---|
| high-dose simvastatin, combined, placebo | Experimental | simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo Receives: Drug: simvastatin, combined with simvastatin ezetimibe, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.
Measured: 8 weeks
Secondary outcomes (1)
biochemical markers
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Escola Bahiana de Medicina e Saude Publica
- Investigators
- Maristela M Garcia, MD, Principal investigator, Escola Bahiana de Medicina e Saúde Pública
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241097
- Sponsor's protocol ID
- sxse
- Status last verified
- Jun 2010
- First submitted
- 15 Nov 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect on Endothelial Function of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe
- ClinicalTrials.gov ID
- NCT01241097
- Acronym / sponsor ID
- sxse
- Conditions
- Endothelial Function
- Keywords
- endothelial function, statins, ezetimibe, pleiotropism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- Escola Bahiana de Medicina e Saude Publica
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Nov 2010 (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.
- To test the hypothesis that therapy with high dose statin provides endothelial superior benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.
- To test the hypothesis that therapy with high dose statin provides anti-inflammatory effect than the same reduction of cholesterol with low dose of statin plus ezetimibe
Detailed description
Randomized, double-blind, placebo-controlled study. Inclusion Criteria: Obese women with body mass index (BMI)> 25 kg / m², aged 18 years and LDL-C> 100 mg / dl For treatment with simvastatin 80 mg, the participant will receive two identical vials, each containing a simvastatin 40 mg. For treatment with the combination simvastatin 10 mg and ezetimibe 10 mg, the participant will receive two identical bottles, one bottle with simvastatin 10 mg, and another bottle with ezetimibe 10mg. In the control group, each participant will receive two identical bottles, each bottle containing inert tablets. Each group with 20 participants.
Dependent Variable (Final Primary Outcome): Percentage change vasodilation of brachial artery flow-mediated, after treatment for eight weeks.
Covariates: clinical, biochemical markers and ultrasound.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-dose simvastatin, combined, placebo | Experimental | Drug: simvastatin, combined with simvastatin ezetimibe, placebosimvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with body mass index (BMI)> 25 kg / m²
- Aged > 18 years
- LDL-C> 100 mg / dl
Key exclusion criteria (12 listed)
- Previous use of statins, fibrates or ezetimibe
- Triglycerides> 400 mg / dl
- Serum creatinine greater than 2.0 md / dl
- Elevated liver enzymes, more than one and half times the upper limit of normal
- Creatine kinase (CK) levels more than three times the upper limit of normal
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 |
|---|---|---|
| simvastatin, combined with simvastatin ezetimibe, placeboAlso: zocor, vytorinsimvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo | Drug | high-dose simvastatin, combined, placebo |
Primary outcome
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.
Time frame: 8 weeks
1 secondary outcome
biochemical markers
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
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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.
Maristela M Garcia, MD principal investigator
Escola Bahiana de Medicina e Saúde Pública
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Endothelial Function, run by Federal University of Bahia at 1 site in Brazil.
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 12 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: status not confirmed, as of the sponsor's last update on 16 Nov 2010. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maristela M Garcia, MD (55-71-99739981, marismacardiol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment. (time frame: 8 weeks). 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 16 Nov 2010.