NCT00136799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

August 25, 2005

Last Update Submit

February 20, 2017

Conditions

Mixed DyslipidemiaHypercholesterolemia

Keywords

Mixed Dyslipidemiahigh cholesteroladultsfluvastatin

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcomes (3)

  • 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

Interventions

FluvastatinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mixed dyslipidemia
  • Primary hypercholesterolemia

You may not qualify if:

  • Pregnant or lactating women
  • Age \> 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Shanghai, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Novartis

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

June 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

CN(1)