Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome
LesScore
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%
1 other identifier
interventional
144
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 12, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2009
CompletedMarch 1, 2017
February 1, 2017
1.7 years
January 12, 2009
February 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
9 months
Secondary Outcomes (3)
Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables)
9 month
Proportion of patients with controlled glycemia
9 months
Percentage of patients no longer classifiable as having metabolic syndrome
9 months
Study Arms (3)
1
EXPERIMENTALFluvastatin: daily 80 mg, oral
2
EXPERIMENTALValsartan
3
EXPERIMENTALHydrochlorothiazide
Interventions
Eligibility Criteria
You may qualify if:
- Age between 40 - 65 years
- Diagnosed metabolic syndrome
- Risk of cardiovascular death ≥ 5% (according to SCORE)
- Written informed consent
You may not qualify if:
- Women not in menopause or not using efficient contraception
- Known hypersensitivity to study drugs
- History of ischemic heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Related Publications (1)
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.
PMID: 23334870RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Rossi, MD
ASL Terni 4, Narni (TR) - Italy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2009
First Posted
January 13, 2009
Study Start
July 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
March 1, 2017
Record last verified: 2017-02