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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01234922
First received: November 3, 2010
Last updated: December 9, 2014
Last verified: December 2014
Results First Received: December 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: lisinopril
Drug: losartan potassium
Other: laboratory biomarker analysis
Drug: benazepril hydrochloride
Drug: ramipril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol was closed early due to slow accrual

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm I     Arm II     Arm III     Arm IV  
STARTED     1     1     2     2  
COMPLETED     1     1     2     2  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Arm III     Arm IV     Total  
Number of Participants  
[units: participants]
  1     1     2     2     6  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     1     0     2     1     4  
>=65 years     0     1     0     1     2  
Age  
[units: years]
Mean (Standard Deviation)
  46.1  (0)     68.8  (0)     62.2  (1.45)     65.5  (6.15)     61.7  (8.19)  
Gender  
[units: participants]
         
Female     0     0     0     2     2  
Male     1     1     2     0     4  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     0     0     0     0     0  
Not Hispanic or Latino     1     1     2     2     6  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     0     0     0     0     0  
White     1     1     2     2     6  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     1     1     2     2     6  



  Outcome Measures

1.  Primary:   Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter   [ Time Frame: 7 days post-baseline ]

2.  Secondary:   Change in Ang II, VEGF, PlGF, and ACE Levels   [ Time Frame: 1 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: William J. Petty, MD
Organization: Wake Forest Baptist Health
phone: 336-716-3313
e-mail: wpetty@wakehealth.edu


No publications provided


Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01234922     History of Changes
Other Study ID Numbers: CCCWFU 98710, NCI-2010-02043, IRB00014933
Study First Received: November 3, 2010
Results First Received: December 9, 2014
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board