NCT00821574CompletedPhase 4
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%
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 144
- Primary Endpoint
- Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 40 - 65 years
- •Diagnosed metabolic syndrome
- •Risk of cardiovascular death ≥ 5% (according to SCORE)
- •Written informed consent
Exclusion Criteria
- •Women not in menopause or not using efficient contraception
- •Known hypersensitivity to study drugs
- •History of ischemic heart disease
Arms & Interventions
1
Experimental
Fluvastatin: daily 80 mg, oral
Intervention: Fluvastatin (Drug)
2
Experimental
Valsartan
Intervention: Valsartan (Drug)
3
Experimental
Hydrochlorothiazide
Intervention: Hydrochlorothiazide (Drug)
Outcomes
Primary Outcomes
Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
Time Frame: 9 months
Secondary Outcomes
- 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)
Investigators
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