NCT00171288

Brief Summary

The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

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

August 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

September 12, 2005

Last Update Submit

November 7, 2011

Conditions

Dyslipidemia

Keywords

Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcomes (2)

  • Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks

  • Change from baseline in circulating marker of inflammation after 12 weeks

Interventions

fluvastatin, ezetimibeDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-75 Primary hypercholesterolemia Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Madrid, Spain

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

FluvastatinEzetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAzetidinesAzetinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

ES(1)