- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7.
|
Correlative studies
Given orally
Other Names:
|
EXPERIMENTAL: Arm II
Patients receive oral lisinopril once daily on days 1-7.
|
Correlative studies
Given orally
Other Names:
|
EXPERIMENTAL: Arm III
Patients receive oral ramipril twice daily on days 1-7.
|
Correlative studies
Given orally
Other Names:
|
EXPERIMENTAL: Arm IV
Patients receive oral losartan potassium once daily on days 1-7.
|
Correlative studies
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
Time Frame: 7 days post-baseline
|
7 days post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Ang II, VEGF, PlGF, and ACE Levels
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Protective Agents
- Cardiotonic Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Losartan
- Benazepril
- Ramipril
- Lisinopril
Other Study ID Numbers
- IRB00014933 (OTHER: WFUHS IRB)
- NCI-2010-02043 (OTHER: CTRP)
- CCCWFU 98710 (OTHER: Wake Forest University Health Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
Clinical Trials on laboratory biomarker analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed