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Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Fluvastatin

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, adults, fluvastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis

Outcomes

Primary Outcome Measures

Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00125125

First Posted

July 28, 2005

Last Updated

May 15, 2017

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00125125

Brief Title

Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

Dyslipidemia, adults, fluvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

218 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fluvastatin

Primary Outcome Measure Information:

Title

Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measure Information:

Title

Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation

Title

Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks

Title

Number of patients who reach target LDL after 12 weeks

Title

Change from baseline in marker of inflammation after 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

Novartis

City

East Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

City

Investigative Centers

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

18312764

Citation

Stein EA, Ballantyne CM, Windler E, Sirnes PA, Sussekov A, Yigit Z, Seper C, Gimpelewicz CR. Efficacy and tolerability of fluvastatin XL 80 mg alone, ezetimibe alone, and the combination of fluvastatin XL 80 mg with ezetimibe in patients with a history of muscle-related side effects with other statins. Am J Cardiol. 2008 Feb 15;101(4):490-6. doi: 10.1016/j.amjcard.2007.09.099. Epub 2007 Dec 20.

Results Reference

derived

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Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

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