Phase 4
Completed N=30
Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine
Source: ClinicalTrials.gov NCT01603940 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Endothelial Function — 9.4; 8.8 percentage of maximal vasodilation — p=0.616
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Function |
9.4; 8.8 | 0.616 |
| SECONDARY Vascular Stiffness |
8.5; 8.5 | 0.28 |
| SECONDARY Systolic Blood Pressure |
134; 139 | 0.618 |
| SECONDARY Diastolic Blood Pressure |
80; 82 | — |
| SECONDARY Vascular Stiffness by Augmentation Index |
28; 35 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01603940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.