NCT00138528

Brief Summary

Other effects of fluvastatin are investigated in German patients with metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2004

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

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

August 25, 2005

Last Update Submit

February 20, 2017

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome, fluvastatin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks

Secondary Outcomes (5)

  • Change from baseline in low density lipoprotein cholesterol after 5 weeks

  • Change from baseline in non high density lipoprotein cholesterol after 5 weeks

  • Change from baseline in total cholesterol after 5 weeks

  • Change from baseline in high density lipoprotein cholesterol after 5 weeks

  • Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks

Interventions

FluvastatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Male and female patients, aged between 18 and 75 years
  • Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)

You may not qualify if:

  • History of heart failure
  • HIV positive
  • Stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Nuremberg, Germany

Location

Related Publications (1)

  • Westphal S, Abletshauser C, Luley C. Fluvastatin treatment and withdrawal: effects on endothelial function. Angiology. 2008 Oct-Nov;59(5):613-8. doi: 10.1177/0003319708316005. Epub 2008 Apr 14.

    PMID: 18413332RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 30, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

DE(1)