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Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: July 28, 2005
Last updated: May 15, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: Double
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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00125125

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00125125     History of Changes
Other Study ID Numbers: CXUO320B2406
Study First Received: July 28, 2005
Last Updated: May 15, 2017

Keywords provided by Novartis:
Dyslipidemia, adults, fluvastatin

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017