NCT00538967

Brief Summary

The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA progression, and contradictory findings in human studies evaluating the effect of doxycycline therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9 inhibition, and that the effect may be dose dependent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

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

May 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
Last Updated

October 3, 2007

Status Verified

October 1, 2007

First QC Date

October 2, 2007

Last Update Submit

October 2, 2007

Conditions

Aortic Aneurysm, Abdominal

Keywords

CollagenasesMMPCathepsinsDoxycyclineAneurysm

Outcome Measures

Primary Outcomes (1)

  • Collagenase mRNA and protein expression

    2 weeks

Study Arms (4)

1

NO INTERVENTION

2

ACTIVE COMPARATOR

doxycycline 50 mg/day

Drug: doxycycline

3

ACTIVE COMPARATOR

doxycycline 100 mg

Drug: doxycycline

4

ACTIVE COMPARATOR

doxycycline 300 mg

Drug: doxycycline

Interventions

doxycyclineDRUG

2 weeks once daily

234

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elective open aneurysm repair

You may not qualify if:

  • Severe kidney and liver dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAneurysm

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jan HN Lindeman, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 3, 2007

Study Start

May 1, 2002

Study Completion

August 1, 2005

Last Updated

October 3, 2007

Record last verified: 2007-10

Locations

NL(1)