Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

Phase 4

Completed

• Conditions: Hypertension, Dyslypidaemia
• Interventions: Drug: Fluvastatin; Drug: Hydrochlorothiazide; Drug: Valsartan

• 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

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

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