Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00125125
First received: July 28, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: Fluvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Enrollment: 218
Study Start Date: May 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125125

Locations
United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00125125     History of Changes
Other Study ID Numbers: CXUO320B2406
Study First Received: July 28, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Dyslipidemia, adults, fluvastatin

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014