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NCT00538967 Clinical Trial

The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00538967
Other study ID # P00.146
Secondary ID
Status Completed
Phase Phase 2
First received October 2, 2007
Last updated October 2, 2007
Start date May 2002
Est. completion date August 2005

Study information
Verified date October 2007
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.

Description:

In this clinical trial, we evaluated the effect of two weeks of low (50 mg/day), medium (100 mg/day) or high dose (300 mg/day) doxycycline versus no medication in patients undergoing elective AAA repair. The effect of doxycycline treatment on MMP and cysteine proteases, and their respective inhibitors was evaluated in an integrative approach.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Elective open aneurysm repair

Exclusion Criteria:

- Severe kidney and liver dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• doxycycline
2 weeks once daily

Locations
Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (1)
Lead Sponsor Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collagenase mRNA and protein expression 2 weeks
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