Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and… (NCT01425242) | Clinical Trial Compass
TerminatedNot Applicable
Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension
Stopped: Insufficient number of participants
Netherlands3 participantsStarted 2011-09
Plain-language summary
Inflammation of the blood vessel plays an important role in the development and growth of a dilated abdominal aorta. An elevated blood pressure leads to an increase in inflammation, therefore blood pressure lowering is an important part of the treatment of patients with a dilated abdominal aorta who also have an elevated blood pressure. In the investigators study the investigators compare the anti-inflammatory effects of 2 different blood pressure lowering strategies. The investigators hypothesize that both strategies will decrease inflammation, however the investigators believe the total decrease of inflammation depends on the type of blood pressure lowering medication used.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with a proven AAA of \>30 mm and \< 55 mm
✓. Age between 18 and 75y (both inclusive)
✓. Weight \> 50 kg
✓. Mild to moderate hypertension (defined as 130 \< msSBP \< 180 or 85\< msDBP \<110), at screening and/or baseline, without current antihypertensive medication.
Exclusion criteria
✕. Patients without an AAA, or with an AAA ≥ 55 mm, or ≤ 30 mm
✕. Patients with an AAA who are eligible for surgical repair for any reason
✕. Diabetes mellitus
✕. Inability of the subjects to switch from all prior antihypertensive medications safely as required by the protocol and need for drugs other than study drugs at the time of baseline
✕. Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg) at screening and/or baseline
✕. Known or suspected contraindications, including history of allergy or hypersensitivity (such as angioedema) to DRIs, CCBs, ACEIs, statins, acetylsalicylic acid or diuretics in general (for example, to aliskiren / amlodipine / hydrochlorothiazide / statins)
✕. Concomitant drugs that are strong inhibitors of CYP3A4 or P-glycoprotein inhibitors (ketoconazole, itraconazole, nefazodone, clarithromycin, ritonavir, nelfinavir, cyclosporine, verapamil, quinidine)