HypertensionPhase 2NCT01234922

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

A Phase 2 study testing lisinopril, losartan potassium and laboratory biomarker analysis in people with Hypertension and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: lisinopril, losartan potassium and laboratory biomarker analysis
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

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
Being tested: lisinopril, losartan potassium, laboratory biomarker analysis, benazepril hydrochloride, ramipril
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lisinoprilDrug
Also called Prinivil, Zestril
Given orally
losartan potassiumDrug
Also called Cozaar
Given orally
laboratory biomarker analysisOther
Correlative studies
benazepril hydrochlorideDrug
Also called benazepril HCl, CGS14824A, Lotensin
Given orally
ramiprilDrug
Also called Altace
Given orally

Study groups in NCT01234922
Study group	Role	What they receive
Arm I	Experimental	Patients receive oral benazepril hydrochloride once daily on days 1-7. Receives: Other: laboratory biomarker analysis; Drug: benazepril hydrochloride
Arm II	Experimental	Patients receive oral lisinopril once daily on days 1-7. Receives: Drug: lisinopril; Other: laboratory biomarker analysis
Arm III	Experimental	Patients receive oral ramipril twice daily on days 1-7. Receives: Other: laboratory biomarker analysis; Drug: ramipril
Arm IV	Experimental	Patients receive oral losartan potassium once daily on days 1-7. Receives: Drug: losartan potassium; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Change in Ang II, VEGF, PlGF, and ACE Levels
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Apr 2014

First posted4 Nov 2010 (estimated)
Study startFeb 2011
Primary completionDec 2013
Study completionApr 2014

Why it stopped: slow accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01234922
Sponsor's protocol ID: IRB00014933
Other IDs: NCI-2010-02043, IRB00014933, CCCWFU 98710
Status last verified: Jul 2018
First submitted: 3 Nov 2010
Last updated: 28 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension
ClinicalTrials.gov ID: NCT01234922
Acronym / sponsor ID: IRB00014933
Conditions: Hypertension, Unspecified Adult Solid Tumor, Protocol Specific
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow accrual
Enrolment: 6 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: Feb 2011
Primary completion: Dec 2013 (actual)
Study completion: Apr 2014 (actual)
First posted: 4 Nov 2010 (estimated)
Results: Posted 15 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm I	Experimental	Other: laboratory biomarker analysis, Drug: benazepril hydrochloridePatients receive oral benazepril hydrochloride once daily on days 1-7.
Arm II	Experimental	Drug: lisinopril, Other: laboratory biomarker analysisPatients receive oral lisinopril once daily on days 1-7.
Arm III	Experimental	Other: laboratory biomarker analysis, Drug: ramiprilPatients receive oral ramipril twice daily on days 1-7.
Arm IV	Experimental	Drug: losartan potassium, Other: laboratory biomarker analysisPatients receive oral losartan potassium once daily on days 1-7.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lisinoprilAlso: Prinivil, ZestrilGiven orally	Drug	Arm II
losartan potassiumAlso: CozaarGiven orally	Drug	Arm IV
laboratory biomarker analysisCorrelative studies	Other	Arm I, Arm II, Arm III, Arm IV
benazepril hydrochlorideAlso: benazepril HCl, CGS14824A, LotensinGiven orally	Drug	Arm I
ramiprilAlso: AltaceGiven orally	Drug	Arm III

Primary outcome

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

1 secondary outcome

Change in Ang II, VEGF, PlGF, and ACE Levels
Time frame: 1 week

Results and safety

Results posted to the registry on 15 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I	1	1
Arm II	1	1
Arm III	2	2
Arm IV	2	2

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

Time frame: 7 days post-baseline. Mean (Standard Deviation). Unit: Picogram/milliliter

Measure	Arm I n = 1	Arm II n = 1	Arm III n = 2	Arm IV n = 2
Value	13.25 (0)	33.67 (0)	6.685 (10.815)	5.045 (5.275)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for 7 days after dosing. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I	0 of 1 (0%)	1 of 1 (100%)	Not reported
Arm II	0 of 1 (0%)	1 of 1 (100%)	Not reported
Arm III	0 of 2 (0%)	1 of 2 (50%)	Not reported
Arm IV	0 of 2 (0%)	2 of 2 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Petty principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter (time frame: 7 days post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01234922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.