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

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ClinicalTrials.gov Identifier: NCT00136799
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Mixed Dyslipidemia Hypercholesterolemia Drug: Fluvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
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
Study Start Date : June 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. Percent change from baseline in total cholesterol after 12 weeks
  2. Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
  3. Percent change from baseline in total triglycerides after 12 weeks


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.


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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00136799     History of Changes
Other Study ID Numbers: CXUO320B2302
First Posted: August 29, 2005    Key Record Dates
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