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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
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 belowSelect...
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:Select...
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
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
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.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,902 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious lung condition.I haven't had a serious brain condition like a stroke or seizure in the last 6 months.My type 2 diabetes is not well-managed, with a HgbA1c over 9%.I have low blood pressure or symptoms of it.I have high blood pressure that hasn't been treated, measured over 130 mmHg three times.I use my asthma inhaler more than once a week.You have experienced angioedema in the past.I understand the details and risks of the study.You have a history of drinking too much alcohol or using drugs.I have not taken long-term steroids in the past year.I have a stomach or bowel problem that affects how medicines work in my body.I am not allergic to the study drugs or similar medications.I have a history of serious heart disease, excluding high blood pressure and thickened heart muscle.Your blood potassium level is higher than 5.2 mmol/L during the screening or higher than 5.4 mmol/L during the study.I do not take regular medication for a condition that could affect the study.My kidney function is low, with an eGFR below 30 mL/min.I have been postmenopausal for at least one year.I have had cancer other than non-melanoma skin cancer.I have Type 1 diabetes.I have high blood pressure with symptoms or readings above 170/110 mmHg.I am currently using hormone-replacement therapy.I am currently taking lithium.My liver tests (AST or ALT) are more than three times the normal limit.Your hematocrit level is less than 35%.My high blood pressure is caused by another health condition.I have a history of immune or blood disorders.You are currently breastfeeding or pregnant.I have been on blood pressure medication for at least six months.I am a smoker or use oral contraceptives and understand the risk of blood clots with arterial line placement.I have had pancreatitis or have known pancreatic lesions.I have high blood pressure that hasn't been treated, measured three times.
Research Study Groups:
This trial has the following groups:- Group 1: valsartan then LCZ696
- Group 2: LCZ696 then valsartan
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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