Trial Outcomes & Findings for Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine (NCT NCT01603940)
NCT ID: NCT01603940
Last Updated: 2016-02-01
Results Overview
Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-02-01
Participant Flow
Participant milestones
| Measure |
Losartan
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine
Baseline characteristics by cohort
| Measure |
Losartan
n=16 Participants
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 Participants
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksAccess endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.
Outcome measures
| Measure |
Losartan
n=16 Participants
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 Participants
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Endothelial Function
|
9.4 percentage of maximal vasodilation
Interval 7.7 to 13.5
|
8.8 percentage of maximal vasodilation
Interval 6.9 to 11.0
|
SECONDARY outcome
Timeframe: 12 weeks.Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).
Outcome measures
| Measure |
Losartan
n=16 Participants
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 Participants
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Vascular Stiffness
|
8.5 m/s
Interval 7.0 to 9.7
|
8.5 m/s
Interval 7.8 to 9.4
|
SECONDARY outcome
Timeframe: 12 weeksCompare both groups effects on systolic blood pressure.
Outcome measures
| Measure |
Losartan
n=16 Participants
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 Participants
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Systolic Blood Pressure
|
134 mmHg
Interval 127.0 to 143.0
|
139 mmHg
Interval 130.0 to 154.0
|
SECONDARY outcome
Timeframe: 12 weeksCompare both group effects on diastolic blood pressure.
Outcome measures
| Measure |
Losartan
n=16 Participants
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 Participants
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Diastolic Blood Pressure
|
80 mmHg
Interval 69.0 to 84.0
|
82 mmHg
Interval 74.0 to 89.0
|
SECONDARY outcome
Timeframe: 12 weeksEstimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.
Outcome measures
| Measure |
Losartan
n=16 Participants
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 Participants
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Vascular Stiffness by Augmentation Index
|
28 percentage of augmentation pressure
Interval 21.0 to 37.0
|
35 percentage of augmentation pressure
Interval 26.0 to 41.0
|
Adverse Events
Losartan
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Benazepril
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Losartan
n=16 participants at risk
This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
|
Benazepril
n=14 participants at risk
This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema
|
12.5%
2/16 • Number of events 2
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
Additional Information
Ronaldo Altenburg Gismondi, MD, PhD
Hospital Universitario Pedro Ernesto (UERJ)
Phone: +5521996092383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place