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. |
ClinicalTrials.gov Identifier: NCT00821574 |
Recruitment Status :
Completed
First Posted : January 13, 2009
Last Update Posted : March 1, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension, Dyslypidaemia | Drug: Fluvastatin Drug: Valsartan Drug: Hydrochlorothiazide | Phase 4 |
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 |

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 |
- Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm [ Time Frame: 9 months ]
- Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables) [ Time Frame: 9 month ]
- Proportion of patients with controlled glycemia [ Time Frame: 9 months ]
- Percentage of patients no longer classifiable as having metabolic syndrome [ Time Frame: 9 months ]

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.
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

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
Principal Investigator: | Alessandro Rossi, MD | ASL Terni 4, Narni (TR) - Italy |
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 |
Hypertension, dyslipidemia |
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 |