Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Novartis218 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

218

Conditions

Dyslipidemia

Interventions

FluvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Dyslipidemia * History of Myalgia Exclusion Criteria: * Previous treatment with fluvastatin * Age \< 18 years Other protocol-defined inclusion and exclusion criteria may apply.

Locations (2)

Novartis

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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