Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014