Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome
Phase 4
Completed
- Conditions
- Hypertension, Dyslypidaemia
- Interventions
- Registration Number
- NCT00821574
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 Fluvastatin Fluvastatin: daily 80 mg, oral 3 Hydrochlorothiazide Hydrochlorothiazide 2 Valsartan Valsartan
- Primary Outcome Measures
Name Time Method Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm 9 months
- Secondary Outcome Measures
Name Time Method 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