Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00125125

First received: July 28, 2005

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Purpose

The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.

Condition	Intervention	Phase
Dyslipidemia	Drug: Fluvastatin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Fluvastatin Fluvastatin sodium

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures:

Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation
Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks
Number of patients who reach target LDL after 12 weeks
Change from baseline in marker of inflammation after 12 weeks

Enrollment:	218
Study Start Date:	May 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Dyslipidemia
History of Myalgia

Exclusion Criteria:

Previous treatment with fluvastatin
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: NCT00125125

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Additional Information:

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stein EA, Ballantyne CM, Windler E, Sirnes PA, Sussekov A, Yigit Z, Seper C, Gimpelewicz CR. Efficacy and tolerability of fluvastatin XL 80 mg alone, ezetimibe alone, and the combination of fluvastatin XL 80 mg with ezetimibe in patients with a history of muscle-related side effects with other statins. Am J Cardiol. 2008 Feb 15;101(4):490-6. Epub 2007 Dec 20.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00125125 History of Changes
Other Study ID Numbers:	CXUO320B2406
Study First Received:	July 28, 2005
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Dyslipidemia, adults, fluvastatin

Additional relevant MeSH terms:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

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