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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
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

Condition Intervention Phase
Drug: fluvastatin, ezetimibe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 83
Study Start Date: August 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00171288

Madrid, Spain
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Identifier: NCT00171288     History of Changes
Other Study ID Numbers: CXUO320BES03
Study First Received: September 12, 2005
Last Updated: November 7, 2011

Keywords provided by Novartis:
Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017