Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

This study has been completed.

First Received: August 25, 2005 Last Updated: February 8, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00136799

Purpose

The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a Chinese population. This study is not recruiting patients in the US.

Condition	Intervention	Phase
Mixed Dyslipidemia Hypercholesterolemia	Drug: Fluvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Fluvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Further study details as provided by Novartis:

Primary Outcome Measures:

Percent change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures:

Percent change from baseline in total cholesterol after 12 weeks
Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Percent change from baseline in total triglycerides after 12 weeks

Estimated Enrollment:	320
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mixed dyslipidemia
Primary hypercholesterolemia

Exclusion Criteria:

Pregnant or lactating women
Age > 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136799

Locations

China
Novartis
Shangai, China

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CXUO320B2302
Study First Received:	August 25, 2005
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00136799 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Novartis:

Mixed Dyslipidemia
high cholesterol
adults
fluvastatin

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Metabolic Disorder
Hypercholesterolemia
Fluvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Fluvastatin
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009