Trial Outcomes & Findings for Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors (NCT NCT01234922)
NCT ID: NCT01234922
Last Updated: 2018-08-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
7 days post-baseline
Results posted on
2018-08-28
Participant Flow
Protocol was closed early due to slow accrual
Participant milestones
| Measure |
Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally
|
Arm II
Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm III
Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally
|
Arm IV
Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Arm I
n=1 Participants
Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally
|
Arm II
n=1 Participants
Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm III
n=2 Participants
Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally
|
Arm IV
n=2 Participants
Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 0 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 0 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 1.45 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 6.15 • n=4 Participants
|
61.7 years
STANDARD_DEVIATION 8.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 days post-baselineOutcome measures
| Measure |
Arm I
n=1 Participants
Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally
|
Arm II
n=1 Participants
Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm III
n=2 Participants
Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally
|
Arm IV
n=2 Participants
Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|
|
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
|
13.25 Picogram/milliliter
Standard Deviation 0
|
33.67 Picogram/milliliter
Standard Deviation 0
|
6.685 Picogram/milliliter
Standard Deviation 10.815
|
5.045 Picogram/milliliter
Standard Deviation 5.275
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Data were not analyzed due to insufficient accrual to the study and lack of statistical power.
Outcome measures
Outcome data not reported
Adverse Events
Arm I
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm II
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm III
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I
n=1 participants at risk
Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally
|
Arm II
n=1 participants at risk
Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm III
n=2 participants at risk
Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally
|
Arm IV
n=2 participants at risk
Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|
|
Investigations
Hemoglobin
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
|
Investigations
hyperglycemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
|
General disorders
Pain, Chest
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
|
Investigations
lymphopenia
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
|
Gastrointestinal disorders
vomitting
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
|
Vascular disorders
hypertension
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
100.0%
2/2 • Number of events 2 • Adverse events were collected for 7 days after dosing
|
|
General disorders
fatigue
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/1 • Adverse events were collected for 7 days after dosing
|
0.00%
0/2 • Adverse events were collected for 7 days after dosing
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for 7 days after dosing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place