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Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome (LesScore)

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ClinicalTrials.gov Identifier: NCT00821574
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension, Dyslypidaemia Drug: Fluvastatin Drug: Valsartan Drug: Hydrochlorothiazide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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%
Study Start Date : July 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Fluvastatin: daily 80 mg, oral
 Drug: Fluvastatin
Fluvastatin: daily 80 mg, oral
Other Name: Lescol
Experimental: 2
Valsartan
 Drug: Valsartan
Valsartan: daily 160 mg, oral
Other Name: Diovan
Experimental: 3
Hydrochlorothiazide
 Drug: Hydrochlorothiazide
Hydrochlorothiazide: daily 12.5mg, oral


Outcome Measures
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Primary Outcome Measures :
  1. Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables) [ Time Frame: 9 month ]
  2. Proportion of patients with controlled glycemia [ Time Frame: 9 months ]
  3. Percentage of patients no longer classifiable as having metabolic syndrome [ Time Frame: 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821574


Sponsors and Collaborators
Novartis
Investigators
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Principal Investigator: Alessandro Rossi, MD ASL Terni 4, Narni (TR) - Italy
More Information
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Publications of Results:

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00821574    
Other Study ID Numbers: CXUO320BIT02
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Novartis:
Hypertension, dyslipidemia
Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Valsartan
Hydrochlorothiazide
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators