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Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

NCT ID: NCT00821574

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension, Dyslypidaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Fluvastatin: daily 80 mg, oral

Group Type EXPERIMENTAL

Fluvastatin

Intervention Type DRUG

Fluvastatin: daily 80 mg, oral

2

Valsartan

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan: daily 160 mg, oral

3

Hydrochlorothiazide

Group Type EXPERIMENTAL

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide: daily 12.5mg, oral

Interventions

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Fluvastatin

Fluvastatin: daily 80 mg, oral

Intervention Type DRUG

Valsartan

Valsartan: daily 160 mg, oral

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide: daily 12.5mg, oral

Intervention Type DRUG

Other Intervention Names

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Lescol Diovan

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

ASL Terni 4, Narni (TR) - Italy

References

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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.

Reference Type RESULT
PMID: 23334870 (View on PubMed)

Other Identifiers

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CXUO320BIT02

Identifier Type: -

Identifier Source: org_study_id

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