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Angiotensin Receptor Blocker/Neprilysin Inhibitor

Combination Blood Pressure Therapy for High Blood Pressure

Phase 4

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with essential hypertension defined as having untreated, seated systolic blood pressure (SBP) of 130 mmHg or greater on three separate occasions

For female subjects, postmenopausal status for at least one year

Must not have

Presence of significant pulmonary disorders

History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack within six months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after four-week treatment with each crossover drug

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if a two-drug combination can increase blood flow more than one of the drugs can on its own, and if a third drug can interact with the first two to also increase blood flow.

Who is the study for?

This trial is for adults with high blood pressure who've been on medication for at least six months or have certain levels of untreated blood pressure. Women must be postmenopausal, surgically sterilized, or using birth control. People can't join if they have a history of severe allergies to related drugs, low blood pressure, significant lung disorders, type 1 diabetes, very poor kidney function, recent steroid therapy or drug trials participation.

What is being tested?

The study tests whether combining an angiotensin receptor blocker (Valsartan) and neprilysin inhibitor (LCZ696) affects forearm blood flow and tissue response better than the blocker alone. It also looks at how adding a DPP4 inhibitor (Sitagliptin) changes these effects when exposed to bradykinin, substance P, and BNP.

What are the potential side effects?

Potential side effects may include allergic reactions like swelling under the skin (angioedema), low blood pressure symptoms such as dizziness or fainting especially after standing up quickly from sitting/lying down position; possible impacts on liver function; increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high blood pressure that hasn't been treated, measured over 130 mmHg three times.

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I have been postmenopausal for at least one year.

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I have been on blood pressure medication for at least six months.

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I have high blood pressure that hasn't been treated, measured three times.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious lung condition.

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I haven't had a serious brain condition like a stroke or seizure in the last 6 months.

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My type 2 diabetes is not well-managed, with a HgbA1c over 9%.

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I have low blood pressure or symptoms of it.

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I use my asthma inhaler more than once a week.

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I understand the details and risks of the study.

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I have not taken long-term steroids in the past year.

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I have a stomach or bowel problem that affects how medicines work in my body.

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I have a history of serious heart disease, excluding high blood pressure and thickened heart muscle.

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My kidney function is low, with an eGFR below 30 mL/min.

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I have had cancer other than non-melanoma skin cancer.

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I have Type 1 diabetes.

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I am currently taking lithium.

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My liver tests (AST or ALT) are more than three times the normal limit.

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My high blood pressure is caused by another health condition.

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I have a history of immune or blood disorders.

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I have had pancreatitis or have known pancreatic lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after four-week treatment with each crossover drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after four-week treatment with each crossover drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and after four-week treatment with each crossover drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

forearm blood flow

tissue-type plasminogen activator release

Secondary study objectives

norepinephrine release

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: valsartan then LCZ696Active Control6 Interventions

After four-week treatment with valsartan, participants will receive intra-arterial infusions of bradykinin, substance P, and BNP in the presence and absence of sitagliptin. Then, after three-week washout and four week therapy with LCZ696, participants will receive intra-arterial infusions of bradykinin, substance P, and BNP in the presence and absence of sitagliptin.

Group II: LCZ696 then valsartanActive Control6 Interventions

After four-week treatment with LCZ696, participants will receive intra-arterial infusions of bradykinin, substance P, and BNP in the presence and absence of sitagliptin. Then, after three-week washout and four week therapy with valsartan, participants will receive intra-arterial infusions of bradykinin, substance P, and BNP in the presence and absence of sitagliptin.

0 / 21Eligibility criteria met