Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Phase 4

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT00125125
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-07-28
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-07-29
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Dyslipidemia
• History of Myalgia

Exclusion Criteria

• Previous treatment with fluvastatin
• Age < 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States