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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after four-week treatment with each crossover drug
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I have high blood pressure that hasn't been treated, measured three times.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
forearm blood flow
tissue-type plasminogen activator release
Secondary outcome measures
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
849 Previous Clinical Trials
669,005 Total Patients Enrolled

Media Library

LCZ696 (Angiotensin Receptor Blocker/Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03738878 — Phase 4
High Blood Pressure Research Study Groups: valsartan then LCZ696, LCZ696 then valsartan
High Blood Pressure Clinical Trial 2023: LCZ696 Highlights & Side Effects. Trial Name: NCT03738878 — Phase 4
LCZ696 (Angiotensin Receptor Blocker/Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03738878 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination drug of LCZ696 and valsartan been given authorization by the FDA?

"Our team has graded the safety of LCZ696 then valsartan to be a 3, as this treatment is already approved and thus in Phase 4 trials."

Answered by AI

What medical condition is LCZ696 in comparison to valsartan commonly used for?

"LCZ696 followed by valsartan is a common treatment for instances of ventricular dysfunction, left. Moreover, this medication regimen can be utilized to manage essential hypertension that has not been sufficiently managed with single-drug therapy and prophylaxis against cardiovascular events."

Answered by AI

Is it possible to join this clinical research experiment?

"This medical trial is currently enrolling 32 individuals with essential hypertension and aged between 18-60. To be eligible, patients must have had three separate readings of a seated systolic blood pressure (SBP) of 130mmHg or greater, unmediated diastolic BP (DBP) of 80 or higher across 3 occasions, been on antihypertensive medication for at least six months, undergone surgical sterilization if they are fertile and utilize reliable birth control, as well as agree to undertake urine beta hCG testing before drug treatment and every study day."

Answered by AI

Is there an upper limit on the number of participants in this research?

"This trial has concluded its recruitment process, having been posted on November 15th 2018 and last updated on June 1st 2022. For those who are still searching for a suitable study, there are currently 746 trials actively recruiting patients with hypertension as well as 52 studies investigating the efficacy of LCZ696 versus valsartan."

Answered by AI

What other medications has LCZ696 been compared to in prior clinical trials?

"Currently, 52 studies are actively researching the efficacy of LCZ696 combined with valsartan. 12 of these trials have entered Phase 3 and 859 sites across North America are participating in them; however, most of these locations reside in Montreal, Quebec."

Answered by AI

Is participation in this trial restricted to geriatric individuals, or can those under 80 years of age also join?

"This clinical trial is limited to recruitment from those aged 18-60. By contrast, 57 trials are accepting minors and 707 studies are enrolling seniors as participants."

Answered by AI

Is this trial currently seeking new participants?

"According to clinicaltrials.gov, the recruitment efforts for this trial concluded with its last update on June 1st 2022. Despite this study being inactive, there are currently 798 other trials which are actively recruiting participants."

Answered by AI
~6 spots leftby Jul 2025