Hypertension, DyslypidaemiaPhase 4LesScoreNCT00821574
Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome
A Phase 4 study testing Fluvastatin, Valsartan and Hydrochlorothiazide in people with Hypertension, Dyslypidaemia, run by Novartis.
Trial summary
This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension, Dyslypidaemia
- What is being tested?
- Fluvastatin, Valsartan and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Mar 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 - 65 years
- Diagnosed metabolic syndrome
- Risk of cardiovascular death ≥ 5% (according to SCORE)
- Written informed consent
Who cannot join
- Women not in menopause or not using efficient contraception
- Known hypersensitivity to study drugs
- History of ischemic heart disease
About this study
Official title: Project to Promote the Evaluation of the Cardiovascular Risk in the Clinical Practice and to Evaluate Its Evolution Following the Implementation of a Preventive Multifactorial Strategy Aimed to Reduce the Total Risk Level (SCORE Algorithm), in Subjects Suffering From Metabolic Syndrome and With a Risk Level ≥5%
This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.
- Conditions
- Hypertension, Dyslypidaemia
- Being tested
- Fluvastatin, Valsartan, Hydrochlorothiazide
- Keywords
- Hypertension, dyslipidemia
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
Also called Lescol
Fluvastatin: daily 80 mg, oral
ValsartanDrug
Also called Diovan
Valsartan: daily 160 mg, oral
HydrochlorothiazideDrug
Hydrochlorothiazide: daily 12.5mg, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fluvastatin: daily 80 mg, oral Receives: Drug: Fluvastatin |
| 2 | Experimental | Valsartan Receives: Drug: Valsartan |
| 3 | Experimental | Hydrochlorothiazide Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
Measured: 9 months
Secondary outcomes (3)
Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables)
Measured: 9 month
Proportion of patients with controlled glycemia
Measured: 9 months
Percentage of patients no longer classifiable as having metabolic syndrome
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJul 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, DyslypidaemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Rossi, MD, Principal investigator, ASL Terni 4, Narni (TR) - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821574
- Sponsor's protocol ID
- CXUO320BIT02
- Acronym
- LesScore
- Status last verified
- Feb 2017
- First submitted
- 12 Jan 2009
- Last updated
- 1 Mar 2017
- Results posted
- No
Publications
Ambrosioni E, Cicero AF, Parretti D, Filippi A, Rossi A, Peruzzi E, Borghi C. Global cardiovascular disease risk management in italian patients with metabolic syndrome in the clinical practice setting. High Blood Press Cardiovasc Prev. 2008 Apr;15(2):37-45. doi: 10.2165/00151642-200815020-00001. Epub 2013 Jan 3.
PubMed 23334870
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project to Promote the Evaluation of the Cardiovascular Risk in the Clinical Practice and to Evaluate Its Evolution Following the Implementation of a Preventive Multifactorial Strategy Aimed to Reduce the Total Risk Level (SCORE Algorithm), in Subjects Suffering From Metabolic Syndrome and With a Risk Level ≥5%
- ClinicalTrials.gov ID
- NCT00821574
- Acronym / sponsor ID
- LesScore / CXUO320BIT02
- Conditions
- Hypertension, Dyslypidaemia
- Keywords
- Hypertension, dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 13 Jan 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.
This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FluvastatinFluvastatin: daily 80 mg, oral |
| 2 | Experimental | Drug: ValsartanValsartan |
| 3 | Experimental | Drug: HydrochlorothiazideHydrochlorothiazide |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40 - 65 years
- Diagnosed metabolic syndrome
- Risk of cardiovascular death ≥ 5% (according to SCORE)
- Written informed consent
Key exclusion criteria (3 listed)
- Women not in menopause or not using efficient contraception
- Known hypersensitivity to study drugs
- History of ischemic heart disease
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 |
|---|---|---|
| FluvastatinAlso: LescolFluvastatin: daily 80 mg, oral | Drug | 1 |
| ValsartanAlso: DiovanValsartan: daily 160 mg, oral | Drug | 2 |
| HydrochlorothiazideHydrochlorothiazide: daily 12.5mg, oral | Drug | 3 |
Primary outcome
Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
Time frame: 9 months
3 secondary outcomes
Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables)
Time frame: 9 month
Proportion of patients with controlled glycemia
Time frame: 9 months
Percentage of patients no longer classifiable as having metabolic syndrome
Time frame: 9 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 1 Mar 2017.
- Results publication: PubMed 23334870Ambrosioni E, Cicero AF, Parretti D, Filippi A, Rossi A, Peruzzi E, Borghi C. Global cardiovascular disease risk management in italian patients with metabolic syndrome in the clinical practice setting. High Blood Press Cardiovasc Prev. 2008 Apr;15(2):37-45. doi: 10.2165/00151642-200815020-00001. Epub 2013 Jan 3.
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.
Alessandro Rossi, MD principal investigator
ASL Terni 4, Narni (TR) - Italy
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluvastatin, Valsartan and Hydrochlorothiazide in people with Hypertension, Dyslypidaemia, run by Novartis.
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 4 inclusion and 3 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00821574, which also lists 1 linked publication.
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 1 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.