NCT01234922

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	lisinopril	Given orally
DRUG	losartan potassium	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
DRUG	benazepril hydrochloride	Given orally
DRUG	ramipril	Given orally

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2010-11-04
• Last updated: 2018-08-28
• Results posted: 2014-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study