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NCT00136799 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00136799
Other study ID # CXUO320B2302
Secondary ID
Status Completed
Phase Phase 3
First received August 25, 2005
Last updated February 20, 2017
Start date June 2005
Est. completion date April 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 325
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Mixed dyslipidemia

- Primary hypercholesterolemia

Exclusion Criteria:

- Pregnant or lactating women

- Age > 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
China Novartis Shangai

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Percent change from baseline in total cholesterol after 12 weeks
Secondary Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Secondary Percent change from baseline in total triglycerides after 12 weeks
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