Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

May 15, 2017 updated by: Novartis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Investigative Centers, Germany
  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 28, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

July 29, 2005

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXUO320B2406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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