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OpenTrials
Completed

NCT Number: NCT00821574

Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

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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Key information

Conditions

Hypertension, Dyslypidaemia Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvastatin

Drug

Fluvastatin: daily 80 mg, oral

Other names: Lescol

valsartan

Drug

Valsartan: daily 160 mg, oral

Other names: Diovan

Hydrochlorothiazide

Drug

Hydrochlorothiazide: daily 12.5mg, oral

Primary outcomes

  1. Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm

    Time frame: 9 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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%

Acronym: LesScore

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 13, 2009
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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