View Clinical Trial (Medical Research Study)
A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension
| City: |
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Winston-Salem |
| State: |
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North Carolina |
| Zip Code: |
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27157 |
| Conditions: |
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Hypertension - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01234922 |
| Primary Contact: |
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Principal Investigator
William Petty
Wake Forest University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Winston-Salem, North Carolina 27157
United States
William Je Petty
Phone: 336-713-5440
Email: wpetty@wfubmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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