The effect of blood pressure lowering on vessel wall inflammation in patients with a dilated abdominal aorta and moderately elevated blood pressure

• Conditions: Abdominal Aortic AneurysmHypertension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000538-12-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with a proven AAA of >30 mm and < 55 mm
2. Age between 18 and 75y (both inclusive)
3. Weight > 50 kg
4. Mild to moderate hypertension (defined as 130 < msSBP < 180 or 85 < msDBP <110), at screening and/or baseline, without current antihypertensive medication.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Patients without an AAA, or with an AAA = 55 mm, or = 30 mm
2. Patients with an AAA who are eligible for surgical repair for any reason
3. Diabetes mellitus
4. 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
5. Severe hypertension (msSBP =180 mmHg and/or msDBP =110 mmHg) at screening and/or baseline
6. Pregnant or nursing (lactating) women
7. Known or suspected contraindications, including history of allergy or hypersensitivity (such as angioedema) to DRIs, CCBs, ACEIs, statins or diuretics in general (for example, to aliskiren / amlodipine / hydrochlorothiazide / statins)
8. Concomitant drugs that are strong inhibitors of CYP3A4 or P-glycoprotein inhibitors (ketoconazole, itraconazole, nefazodone, rolandeomycin, clarithromycin, ritonavir, nelfinavir, cyclosporine, verapamil, quinidine)
9. Previous or current diagnosis of heart failure (NYHA Class II-IV)
10.Second or third degree heart block without a pacemaker, or potentially life-threatening arrhythmia during the 12 months prior to screening
11.Clinically symptomatic valvular heart disease at screening visit
12.A past medical history of clinically significant ECG abnormalities
13.Confirmed serum potassium =5.3 mEq/L (mmol/L) at screening or baseline.
14.Impaired renal function, defined as eGFR < 45 mL/min/1.73 m2 MDRD
15.Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation
16.Participation in any clinical investigation within four (4) weeks prior to first dose or longer if required by local regulations, and for any other limitation of participation based on local regulations.
17.Patients who have undergone prior radionuclide treatment or examinations or X-ray examinations with a cumulative radiation exposure, which added to the radation exposure of the current study, would exceed local limits.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified