Essential hypertension. MedDRA version: 9.1 Level: LLT Classification code 10059238 MedDRA version: 9.1 Level: LLT Classification code 10007692
Conditions
Interventions
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient eligible for surgical carotid endoarterectomy (urgencies excluded), stable treatment with at least two anti-hypertensive drugs, written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Patient eligible for surgical carotid endoarterectomy (urgencies excluded), stable treatment with at least two anti-hypertensive drugs, written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non menopausal women, severe (stage 3) hypertension, creatinine clearance 50% carotid stenoses. ;Exclusion criteria: Non menopausal women, severe (stage 3) hypertension, creatinine clearance 50% carotid stenoses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effects of a direct renin inhibitor on instability markers of carotid plaques from endoarterectomy. Primary endpoint are semiquantitative variations of mRNA levels of metalloproteasis 1,2,9 and 12.;Secondary Objective: To determine aliskiren effect on central aortic blood pressure. To evaluate genic expression of renin, pro-renin receptor, ACE and AT-1 receptor mRNAs. To determine variations of hsPCR and microalbuminuria. To evaluate metalloproteasis activity using semiquantitative westernblot.;Primary end point(s): Genic expression levels (mRNAs) of metalloproteinases 1,2,9,12.;Main Objective: To determine the effects of a direct renin inhibitor on instability markers of carotid plaques from endoarterectomy. Primary endpoint are semiquantitative variations of mRNA levels of metalloproteasis 1,2,9 and 12.;Secondary Objective: To determine aliskiren effect on central aortic blood pressure. To evaluate genic expression of renin, pro-renin receptor, ACE and AT-1 receptor mRNAs. To determine variations of hsPCR and microalbuminuria. To evaluate metalloproteasis activity using semiquantitative westernblot.;Primary end point(s): Genic expression levels (mRNAs) of metalloproteinases 1,2,9,12. | — |
Countries
Italy
Contacts
Public Contact; ;
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Outcome results
None listed