Official Title: “Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin

Primary Measures

• Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary 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

Inclusion Criteria:

• Dyslipidemia
• History of Myalgia

Exclusion Criteria:

• Previous treatment with fluvastatin
• Age < 18 years
• Other protocol-defined inclusion and exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00125125

Study ID Number: CXUO320B2406

ClinicalTrials.gov Identifier: NCT00125125

Health Authority: United States: Food and Drug Administration

Novartis patient recruitment website