Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00125125

Enrollment

218

Registered

2005-07-29

Start date

2005-05-31

Completion date

2005-12-31

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Dyslipidemia, adults, fluvastatin

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.

Interventions

DRUGFluvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Dyslipidemia * History of Myalgia

Exclusion criteria

* Previous treatment with fluvastatin * Age \< 18 years Other protocol-defined inclusion and

Design outcomes

Primary

Measure	Time frame
Change from baseline in low density lipoprotein cholesterol after 12 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026