FindTrial
Sign In

Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors

A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01234922
Enrollment
6
Registered
2010-11-04
Start date
2011-02-28
Completion date
2014-04-30
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Unspecified Adult Solid Tumor, Protocol Specific

Brief summary

RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure. PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension. SECONDARY OBJECTIVES: I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients. OUTLINE: Patients are randomized to 1 of 4 treatment arms. * ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7. * ARM II: Patients receive oral lisinopril once daily on days 1-7. * ARM III: Patients receive oral ramipril twice daily on days 1-7. * ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms, treatment continues in the absence of unacceptable toxicity.

Interventions

DRUGlisinopril

Given orally

DRUGlosartan potassium

Given orally

OTHERlaboratory biomarker analysis

Correlative studies

DRUGbenazepril hydrochloride

Given orally

DRUGramipril

Given orally

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients must have histologically or cytologically confirmed solid tumor malignancy AND hypertension, defined as a systolic pressure \> 130 OR a diastolic pressure \> 80 * Patients cannot be on active chemotherapy or radiation therapy; start of treatment with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy or radiation therapy * Creatinine \< 2.5 * Potassium \< ULN * Ability to understand and the willingness to sign a written informed consent document * HIV positive patients are eligible to participate in this study

Exclusion criteria

* Patients who are pregnant or nursing due to significant risk to the fetus/infant * Patients who are unable to take oral medications * Patients who are currently taking an ACE-Inhibitor or ARB

Design outcomes

Primary

MeasureTime frame
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter7 days post-baseline

Secondary

MeasureTime frame
Change in Ang II, VEGF, PlGF, and ACE Levels1 week

Countries

United States

Participant flow

Recruitment details

Protocol was closed early due to slow accrual

Participants by arm

ArmCount
Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7. laboratory biomarker analysis: Correlative studies benazepril hydrochloride: Given orally
1
Arm II
Patients receive oral lisinopril once daily on days 1-7. lisinopril: Given orally laboratory biomarker analysis: Correlative studies
1
Arm III
Patients receive oral ramipril twice daily on days 1-7. laboratory biomarker analysis: Correlative studies ramipril: Given orally
2
Arm IV
Patients receive oral losartan potassium once daily on days 1-7. losartan potassium: Given orally laboratory biomarker analysis: Correlative studies
2
Total6

Baseline characteristics

CharacteristicArm IArm IIArm IIIArm IVTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants0 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
1 Participants0 Participants2 Participants1 Participants4 Participants
Age, Continuous46.1 years
STANDARD_DEVIATION 0
68.8 years
STANDARD_DEVIATION 0
62.2 years
STANDARD_DEVIATION 1.45
65.5 years
STANDARD_DEVIATION 6.15
61.7 years
STANDARD_DEVIATION 8.19
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants1 Participants2 Participants2 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants1 Participants2 Participants2 Participants6 Participants
Region of Enrollment
United States
1 participants1 participants2 participants2 participants6 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants2 Participants2 Participants
Sex: Female, Male
Male
1 Participants1 Participants2 Participants0 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
1 / 11 / 11 / 22 / 2
serious
Total, serious adverse events
0 / 10 / 10 / 20 / 2

Outcome results

Primary

Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter

Time frame: 7 days post-baseline

ArmMeasureValue (MEAN)Dispersion
Arm IChanges in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter13.25 Picogram/milliliterStandard Deviation 0
Arm IIChanges in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter33.67 Picogram/milliliterStandard Deviation 0
Arm IIIChanges in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter6.685 Picogram/milliliterStandard Deviation 10.815
Arm IVChanges in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter5.045 Picogram/milliliterStandard Deviation 5.275
Secondary

Change in Ang II, VEGF, PlGF, and ACE Levels

Time frame: 1 week

Population: Data were not analyzed due to insufficient accrual to the study and lack of statistical power.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026