Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine (CONTROL)

December 29, 2015 updated by: Ronaldo Altenburg Odebrecht Curi Gismondi, Hospital Universitario Pedro Ernesto

Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients With Blood Pressure Not Controlled by Amlodipine: Effects on Echocardiographic Parameters, Vascular Stiffness and Endothelial Function.

The purpose of this study is to compare losartan and benazepril in diabetic patients whose high blood pressure is not controlled by amlodipine and its relationship to statin current use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 explain this relationship. Recent publications showed that both ACEi (angiotensin-converting enzyme inhibitor-induced) and ARB (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction.

This study main objective is to assess if ARB (losartan) effects are different from ACEi (benazepril) in endothelial function in patients with diabetes mellitus type 2 and blood pressure not controlled by amlodipine and its relationship to statin current use.

Secondary analysis of vascular stiffness will be measured by pulse wave velocity and augmentation index. Echocardiographic parameters, such as indexes of diastolic function, will also be measured.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20551030
        • Hospital Universitário Pedro Ernesto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 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 stage 4 or 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.
  • Severe mitral regurgitation.
  • Women in fertile age without contraceptive methods in use.
  • Breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Losartan
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Drug: Losartan
Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
Other Names:
  • Cozaar
  • 0006-0951-54
Active Comparator: Benazepril
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Drug: Benazepril
Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
Other Names:
  • Lotensin
  • 0078-0447-05

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Function
Time Frame: 12 weeks
Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular Stiffness
Time Frame: 12 weeks.
Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).
12 weeks.
Systolic Blood Pressure
Time Frame: 12 weeks
Compare both groups effects on systolic blood pressure.
12 weeks
Diastolic Blood Pressure
Time Frame: 12 weeks
Compare both group effects on diastolic blood pressure.
12 weeks
Vascular Stiffness by Augmentation Index
Time Frame: 12 weeks
Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Pedro Ernesto

Investigators

  • Study Chair: Wille Oigman, MD, DSc., Hospital Universitário Pedro Ernesto
  • Study Director: Mario F Neves, MD, DSc., Hospital Universitário Pedro Ernesto
  • Principal Investigator: Ronaldo A Gismondi, MD, MSc., Hospital Universitário Pedro Ernesto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 20, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONTROL STUDY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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