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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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00136799
First received: August 25, 2005
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136799

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00136799     History of Changes
Other Study ID Numbers: CXUO320B2302
Study First Received: August 25, 2005
Last Updated: November 7, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Mixed Dyslipidemia
high cholesterol
adults
fluvastatin

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

ClinicalTrials.gov processed this record on June 17, 2013