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| Sponsor: | Leiden University Medical Center |
|---|---|
| Information provided by: | Leiden University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00538967 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aortic Aneurysm, Abdominal |
Drug: doxycycline |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
| Official Title: | The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm |
| Enrollment: | 60 |
| Study Start Date: | May 2002 |
| Study Completion Date: | August 2005 |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: 1 | |
|
Active Comparator: 2
doxycycline 50 mg/day
|
Drug: doxycycline
2 weeks once daily
|
|
Active Comparator: 3
doxycycline 100 mg
|
Drug: doxycycline
2 weeks once daily
|
|
Active Comparator: 4
doxycycline 300 mg
|
Drug: doxycycline
2 weeks once daily
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300RC | |
| Principal Investigator: | Jan HN Lindeman, MD, PhD | Leiden University Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00538967 History of Changes |
| Other Study ID Numbers: | P00.146 |
| Study First Received: | October 2, 2007 |
| Last Updated: | October 2, 2007 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
Collagenases MMP Cathepsins Doxycycline Aneurysm |
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Aortic Diseases Doxycycline Doxycycline hyclate |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |