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NCT00138528 Clinical Trial

Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00138528
Other study ID # CXUO320BDE30
Secondary ID
Status Completed
Phase Phase 4
First received August 25, 2005
Last updated February 20, 2017
Start date October 2004
Est. completion date February 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Other effects of fluvastatin are investigated in German patients with metabolic syndrome.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Written informed consent

- Male and female patients, aged between 18 and 75 years

- Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)

Exclusion Criteria:

- History of heart failure

- HIV positive

- Stroke

Other protocol defined inclusion and exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
Germany Novartis Nürnberg

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Westphal S, Abletshauser C, Luley C. Fluvastatin treatment and withdrawal: effects on endothelial function. Angiology. 2008 Oct-Nov;59(5):613-8. doi: 10.1177/0003319708316005. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks
Secondary Change from baseline in low density lipoprotein cholesterol after 5 weeks
Secondary Change from baseline in non high density lipoprotein cholesterol after 5 weeks
Secondary Change from baseline in total cholesterol after 5 weeks
Secondary Change from baseline in high density lipoprotein cholesterol after 5 weeks
Secondary Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks
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