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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171288
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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
Dyslipidemia Drug: fluvastatin, ezetimibe Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
  Eligibility

Information from the National Library of Medicine

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

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171288


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171288     History of Changes
Other Study ID Numbers: CXUO320BES03
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors