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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171288

Enrollment

Registered

2005-09-15

Start date

2003-08-31

Completion date

2005-08-31

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin

Brief 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

Interventions

DRUGfluvastatin, ezetimibe

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in low density lipoprotein cholesterol after 12 weeks	—

Secondary

Measure	Time frame
Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks	—
Change from baseline in circulating marker of inflammation after 12 weeks	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026