NCT01409408

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 6, 2012

Status Verified

April 1, 2011

Enrollment Period

2 years

First QC Date

August 1, 2011

Last Update Submit

March 5, 2012

Conditions

HypertensionDiabetes Mellitus

Keywords

HypertensionDiabetes MellitusVascular stiffnessEndothelial function

Outcome Measures

Primary Outcomes (3)

  • Vascular stiffness

    Vascular stiffness will be measured by pulse wave velocity and augmentation index and compared between anlodipine and aliskiren.

    8 weeks

  • Endothelial function

    Access endothelial function by peripheral arterial tonometry and brachial flow-mediated vasodilation and compare it between anlodipine and aliskiren.

    8 weeks

  • Renin activity and concentration

    Access plasma renin activity and concentration and compare it between anlodipine and aliskiren.

    8 weeks

Secondary Outcomes (6)

  • Compare drug effects in office blood pressure measurements to those obtained by home blood pressure monitoring and ambulatory blood pressure monitoring

    8 weeks

  • Assess drugs effects in renin-angiotensin-aldosterone system (RAAS) and correlate it to renin concentration/mass and plasmatic renin activity

    8 weeks

  • Correlation of drug effects and uric acid plasmatic concentration

    8 weeks

  • Correlation of drug effects and glomerular filtration rate

    8 weeks

  • Correlation of drug effects and microalbuminuria

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Aliskiren

ACTIVE COMPARATOR
Drug: Aliskiren

Amlodipine

ACTIVE COMPARATOR
Drug: Amlodipine

Interventions

AliskirenDRUG

300 mg of aliskiren daily for 8 weeks.

Also known as: Rasilez.
Aliskiren
AmlodipineDRUG

Amlodipine 5 mg daily for 8 weeks.

Also known as: Norvasc.
Amlodipine

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, 20551030, Brazil

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

aliskirenAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ronaldo A Gismondi, MD, DsC

    HUPedroernesto (UERJ)

    PRINCIPAL INVESTIGATOR

  • Mario F Neves, MD, PhD

    HUPedroernesto (UERJ)

    STUDY DIRECTOR

  • Wille Oigman, MD, PhD

    HUPedroernesto (UERJ)

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 4, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

December 1, 2013

Last Updated

March 6, 2012

Record last verified: 2011-04

Locations

BR(1)