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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00821574
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):

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

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Fluvastatin: daily 80 mg, oral
Drug: Fluvastatin
Fluvastatin: daily 80 mg, oral
Other Name: Lescol

Experimental: 2
Drug: Valsartan
Valsartan: daily 160 mg, oral
Other Name: Diovan

Experimental: 3
Drug: Hydrochlorothiazide
Hydrochlorothiazide: daily 12.5mg, oral

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT00821574

Sponsors and Collaborators
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Principal Investigator: Alessandro Rossi, MD ASL Terni 4, Narni (TR) - Italy
Publications of Results:
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Responsible Party: Novartis 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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Metabolic Syndrome
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators