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Combination Blood Pressure Therapy for High Blood Pressure
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: valsartan then LCZ696
- Group 2: LCZ696 then valsartan
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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