Abdominal Aortic Aneurysm Hypertension
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Tablet
INN or Proposed INN: ALISKIREN
CAS Number: 173334571
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
INN or Pro
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a proven AAA of >30 mm and 50 kg 4. Mild to moderate hypertension (defined as 130 =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect and variation of 3 and 12 months treatment with Aliskeren-based versus amlodipine-based antihypertensive treatment on aneurismal FDG- uptake;Secondary Objective: To explore the effect of 3 and 12 months treatment with Aliskeren-based versus amlodipine-based antihypertensive treatment on aneurismal growth (diameter), to explore any relationships between aneurismal FDG-uptake, aneurismal diameter, and medical intervention, and to explore the change in FDG-uptake in other large blood vessels (ascending thoracic aorta, descending thoracic aorta, suprarenal abdominal aorta, iliac, and femoral arteries);Primary end point(s): Change from baseline in aneurismal FDG-uptake as measured with PET-CT after 3 and 12 months;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in aneurismal diameter;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Netherlands
Contacts
Public ContactSecretary of vascular surgery
VU University Medical Center
Outcome results
None listed