Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Dyslipidemia Clinical Trial

Official title:

Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171288
• Other study ID #: CXUO320BES03
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 7, 2011
• Start date: August 2003
• Est. completion date: August 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-75 Primary hypercholesterolemia Signed informed consent

Exclusion Criteria:

• Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods

Other protocol defined in and exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• fluvastatin, ezetimibe

Locations

Country	Name	City	State
Spain	Novartis	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary	Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks
Secondary	Change from baseline in circulating marker of inflammation after 12 weeks