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Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136799
First Posted: August 29, 2005
Last Update Posted: February 23, 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 evaluate the safety and tolerability of fluvastatin 80 mg in a Chinese population. This study is not recruiting patients in the US.

Condition Intervention Phase
Mixed Dyslipidemia Hypercholesterolemia Drug: Fluvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcome Measures:
  • Percent change from baseline in total cholesterol after 12 weeks
  • Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
  • Percent change from baseline in total triglycerides after 12 weeks

Enrollment: 325
Study Start Date: June 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (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 to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mixed dyslipidemia
  • Primary hypercholesterolemia

Exclusion Criteria:

  • Pregnant or lactating women
  • 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): NCT00136799


Locations
China
Novartis
Shangai, China
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00136799     History of Changes
Other Study ID Numbers: CXUO320B2302
First Submitted: August 25, 2005
First Posted: August 29, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Mixed Dyslipidemia
high cholesterol
adults
fluvastatin

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
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