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Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125125
First Posted: July 29, 2005
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: July 28, 2005
First Posted: July 29, 2005
Last Update Posted: May 17, 2017
Last Verified: May 2017

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
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors