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

NCT01603940 | Completed Phase 4 Results

• 1 other identifier: CONTROL STUDY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Diabetes Mellitus

Keywords

Hypertension; Diabetes Mellitus; Vascular stiffness; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  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 Outcomes (4)

• Vascular Stiffness

  12 weeks.

• Systolic Blood Pressure

  12 weeks

• Diastolic Blood Pressure

  12 weeks

• Vascular Stiffness by Augmentation Index

  12 weeks

Study Arms (2)

Losartan

ACTIVE COMPARATOR

This group will receive 100 mg of losartan per day. Amlodipine will be maintained.

Drug: Losartan

Benazepril

ACTIVE COMPARATOR

This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.

Drug: Benazepril

Interventions

Benazepril DRUG

Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.

Also known as: Lotensin, 0078-0447-05

Benazepril

Losartan DRUG

Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.

Also known as: Cozaar, 0006-0951-54

Losartan

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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 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.

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead

Study Sites (1)

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, 20551030, Brazil

Location

Related Publications (1)

• Gismondi RA, Bedirian R, Pozzobon CR, Ladeira MC, Oigman W, Neves MF. Renin-Angiotensin System Blockade Associated with Statin Improves Endothelial Function in Diabetics. Arq Bras Cardiol. 2015 Dec;105(6):597-605. doi: 10.5935/abc.20150123. Epub 2015 Oct 2.

  PMID: 26465872 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

benazepril; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Ronaldo Altenburg Gismondi, MD, PhD
• Organization: Hospital Universitario Pedro Ernesto (UERJ)

ronaldogismondi@gmail.com

+5521996092383

Study Officials

• Wille Oigman, MD, DSc.

  Hospital Universitario Pedro Ernesto

  STUDY CHAIR

• Mario F Neves, MD, DSc.

  Hospital Universitario Pedro Ernesto

  STUDY DIRECTOR

• Ronaldo A Gismondi, MD, MSc.

  Hospital Universitario Pedro Ernesto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator. Medical Doctor. Master of Sciences.

Study Record Dates

• First Submitted: May 20, 2012
• First Posted: May 23, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 1, 2016
• Results First Posted: November 11, 2015

Record last verified: 2015-12

Locations

BR (1)