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

NCT01409408 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Aliskiren

300 mg of aliskiren daily for 8 weeks.

DRUG

Amlodipine

Amlodipine 5 mg daily for 8 weeks.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Hospital Universitario Pedro Ernesto

    lead OTHER

Principal Investigators

  • Ronaldo A Gismondi, MD, DsC · HUPedroernesto (UERJ)

  • Mario F Neves, MD, PhD · HUPedroernesto (UERJ)

  • Wille Oigman, MD, PhD · HUPedroernesto (UERJ)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-04-30
Completion
2013-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409408 on ClinicalTrials.gov