HypertensionPhase 4CONTROLNCT01603940

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

A Phase 4 study testing Benazepril and Losartan in people with Hypertension and Diabetes Mellitus, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Hypertension, Diabetes Mellitus
What is being tested?: Benazepril and Losartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteBrazil
Study dates: May 2012to Jan 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Universitario Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551030

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions: Hypertension, Diabetes Mellitus
Being tested: Benazepril, Losartan
Keywords: Hypertension, Diabetes Mellitus, Vascular stiffness, Endothelial function
Medical subject headings: Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BenazeprilDrug
Also called Lotensin, 0078-0447-05
Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
LosartanDrug
Also called Cozaar, 0006-0951-54
Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.

Study groups in NCT01603940
Study group	Role	What they receive
Losartan	Active comparator	This group will receive 100 mg of losartan per day. Amlodipine will be maintained. Receives: Drug: Losartan
Benazepril	Active comparator	This group will receive 20 mg of benazepril per day. Amlodipine will be maintained. Receives: Drug: Benazepril

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jan 2015

First posted23 May 2012 (estimated)
Study startMay 2012
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01603940
Sponsor's protocol ID: CONTROL STUDY
Acronym: CONTROL
Status last verified: Dec 2015
First submitted: 20 May 2012
Last updated: 1 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26465872

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT01603940
Acronym / sponsor ID: CONTROL / CONTROL STUDY
Conditions: Hypertension, Diabetes Mellitus
Keywords: Hypertension, Diabetes Mellitus, Vascular stiffness, Endothelial function
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hospital Universitario Pedro ErnestoUniversity, hospital or other
Study start: May 2012
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 23 May 2012 (estimated)
Results: Posted 11 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Losartan	Active comparator	Drug: LosartanThis group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Benazepril	Active comparator	Drug: BenazeprilThis group will receive 20 mg of benazepril per day. Amlodipine will be maintained.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BenazeprilAlso: Lotensin, 0078-0447-05Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.	Drug	Benazepril
LosartanAlso: Cozaar, 0006-0951-54Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.	Drug	Losartan

Primary outcome

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.

4 secondary outcomes

Vascular Stiffness
Time frame: 12 weeks.
Systolic Blood Pressure
Time frame: 12 weeks
Diastolic Blood Pressure
Time frame: 12 weeks
Vascular Stiffness by Augmentation Index
Time frame: 12 weeks

Results and safety

Results posted to the registry on 11 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan	16	16
Benazepril	14	14

Primary outcome: Endothelial Function

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: percentage of maximal vasodilation

Measure	Losartan n = 16	Benazepril n = 14
Value	9.4 (7.7 to 13.5)	8.8 (6.9 to 11.0)

Losartan vs Benazepril: p = 0.616, Wilcoxon (Mann-Whitney)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Benazepril	0 of 14 (0%)	1 of 14 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26465872Gismondi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wille Oigman, MD, DSc. study chair

Hospital Universitario Pedro Ernesto

Mario F Neves, MD, DSc. study director

Hospital Universitario Pedro Ernesto

Ronaldo A Gismondi, MD, MSc. principal investigator

Hospital Universitario Pedro Ernesto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Benazepril and Losartan in people with Hypertension and Diabetes Mellitus, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial Function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603940, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.