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NCT00125125 Clinical Trial

Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00125125
Other study ID # CXUO320B2406
Secondary ID
Status Completed
Phase Phase 4
First received July 28, 2005
Last updated May 15, 2017
Start date May 2005
Est. completion date December 2005

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 218
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
United States Novartis East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation
Secondary Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks
Secondary Number of patients who reach target LDL after 12 weeks
Secondary Change from baseline in marker of inflammation after 12 weeks
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