Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not controlled by 100 mg per day of losartan.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Pedro Ernesto
• Collaborator: Novartis
• Treatments: Amlodipine; Losartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.