Hypertension, Dyslypidaemia Clinical Trial
— LesScoreOfficial 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%
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | March 2007 |
| Est. primary completion date | March 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
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):37-4 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm | 9 months | ||
| Secondary | Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables) | 9 month | ||
| Secondary | Proportion of patients with controlled glycemia | 9 months | ||
| Secondary | Percentage of patients no longer classifiable as having metabolic syndrome | 9 months |