Metabolic SyndromeNCT00171548
Cardiovascular Risk Evaluation in Clinical Practice in Metabolic Syndrome Patients
An observational study of Metabolic Syndrome, run by Novartis at 1 site in Switzerland.
Trial summary
Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in Italy is 34.1% if… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2004to Jul 2007
- 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 40 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients of both genders aged 40-65 years.
- A diagnosis of metabolic syndrome formulated on the basis of the criteria proposed by the NCEP - Adult Panel III: i.e. the presence of at least three of the following conditions:
- Waist circumference >102 cm in men and >88 cm in women
- Triglyceridemia 150 mg/dl
- HDL cholesterol <40 mg/dl in men and <50 mg/dl in women
- Sitting arterial pressure 130/85 mmHg
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- Fasting glycemia 110 mg/dl
- A risk of cardiovascular death of >5% at the current age of the patient or >5% if projected to an age of 60 years, as calculated by means of the SCORE algorithm using the table based on the total/HDL cholesterol ratio relating to low-risk populations and appropriate for Italy.
- Written informed consent.
Who cannot join
- Women who have not been in menopause for at least one year or are not surgically sterile, and do not use an effective contraceptive method, such as spermicidal barrier methods or intrauterine devices. The use of oral contraceptives is not allowed.
- Known or suspected hypersensitivity to valsartan and/or fluvastatin, or other contraindications to their use;
- A positive history of ischemic heart disease, peripheral artery disease or cerebral vasculopathy;
- Patients with an SBP of 180 mmHg and/or DBP of 110 mmHg.
- Patients with severe medical conditions which, in the judgement of the Investigator, contraindicate trial participation or significantly limit life expectancy;
- Treatment with drugs able to modify the lipid profile (ongoing or in the three months preceding trial entry);
- Patients unable to follow the planned protocol procedures or sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project to Promote the Evaluation of Cardiovascular Risk in Clinical Practice, and Assess Its Evolution After the Implementation of Multifactorial Preventive Strategy Aimed at Reducing the Level of Global Risk (SCORE Algorithm) in Subjects With Metabolic Syndrome and a Risk Level of 5%
Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed using the NCEP-ATPIII criteria.
On the basis of the above considerations, the aim of this study is to promote the use of the SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients with metabolic syndrome after the implementation of a multifactorial preventive strategy, with particular reference to the correction of lifestyle, hypertension and dyslipidemia.
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, cardiovascular risk reduction
- Medical subject headings
- Metabolic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171548
- Sponsor's protocol ID
- CVAL489AIT05
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2005
- Last updated
- 22 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project to Promote the Evaluation of Cardiovascular Risk in Clinical Practice, and Assess Its Evolution After the Implementation of Multifactorial Preventive Strategy Aimed at Reducing the Level of Global Risk (SCORE Algorithm) in Subjects With Metabolic Syndrome and a Risk Level of 5%
- ClinicalTrials.gov ID
- NCT00171548
- Acronym / sponsor ID
- CVAL489AIT05
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, cardiovascular risk reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed using the NCEP-ATPIII criteria.
On the basis of the above considerations, the aim of this study is to promote the use of the SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients with metabolic syndrome after the implementation of a multifactorial preventive strategy, with particular reference to the correction of lifestyle, hypertension and dyslipidemia.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients of both genders aged 40-65 years.
- A diagnosis of metabolic syndrome formulated on the basis of the criteria proposed by the NCEP - Adult Panel III: i.e. the presence of at least three of the following conditions:
- A risk of cardiovascular death of >5% at the current age of the patient or >5% if projected to an age of 60 years, as calculated by means of the SCORE algorithm using the table based on the total/HDL cholesterol ratio relating to low-risk populations and appropriate for Italy.
- Written informed consent.
Key exclusion criteria (7 listed)
- Women who have not been in menopause for at least one year or are not surgically sterile, and do not use an effective contraceptive method, such as spermicidal barrier methods or intrauterine devices. The use of oral contraceptives is not allowed.
- Known or suspected hypersensitivity to valsartan and/or fluvastatin, or other contraindications to their use;
- A positive history of ischemic heart disease, peripheral artery disease or cerebral vasculopathy;
- Patients with an SBP of 180 mmHg and/or DBP of 110 mmHg.
- Patients with severe medical conditions which, in the judgement of the Investigator, contraindicate trial participation or significantly limit life expectancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 22 Sep 2008.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Metabolic Syndrome, run by Novartis at 1 site in Switzerland.
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 9 inclusion and 7 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 22 Sep 2008. 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 Switzerland. 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.
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 22 Sep 2008.