Status:
WITHDRAWN
Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan
Lead Sponsor:
Hospital Universitario Pedro Ernesto
Collaborating Sponsors:
Novartis
Conditions:
Hypertension
Diabetes Mellitus
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and compare theses effects and renin activity and concentration to those obtained with a calcium channel blocker...
Detailed Description
Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may e...
Eligibility Criteria
Inclusion
- Ambulatorial patients with age between 40 and 70 years-old.
- Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
- Those patients without anti-hypertensive drug prescribed in the last 4 weeks with office systolic blood pressure between 140 and 159 mmHg and diastolic between 90 and 109 mmHg.
- Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
- Accepted the consent form.
Exclusion
- Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
- Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
- Evidences of a secondary cause for hypertension
- Glycated hemoglobin A1c \> 9.0%
- Insulin therapy
- Chronic kidney disease of level 3 to 5 or in dialysis
- Advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction \> 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
- Cardiac arrhythmias, except for ectopic beats
- Any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01409408
Start Date
April 1 2011
End Date
December 1 2013
Last Update
March 6 2012
Active Locations (1)
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1
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, Brazil, 20551030