Neprilysin Inhibitor
Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet for High Blood Pressure
Phase 2 & 3
Recruiting
Led By Pankaj Arora, MD, FAHA
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body Mass Index between 30 to 45 kg/m^2
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upat baseline and after 28 days of intervention
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Study Summary
This trial seeks to find a way to lower the risk of cardiovascular events for obese individuals by specifically targeting the natriuretic peptides to control blood pressure.
Eligible Conditions
- High Blood Pressure
- Renin-Angiotensin Aldosterone System
- Natriuretic Peptides
- Cardiovascular Disease
- Obesity
- Nocturnal Hypertension
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a body mass index (BMI) between 30 and 45.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and after 28 days of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and after 28 days of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean nocturnal systolic blood pressure
Secondary outcome measures
Change in 24-hour mean diastolic blood pressure
Change in 24-hour mean systolic blood pressure
Change in 24-hour, daytime, and nocturnal ANP, BNP, NTproBNP, and renin levels
+12 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Sacubitril/Valsartan Morning DoseExperimental Treatment1 Intervention
We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the morning and a placebo pill in the evening for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.
Group II: Sacubitril/Valsartan Evening DoseExperimental Treatment1 Intervention
We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the evening and a placebo pill in the morning for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.
Group III: Valsartan Morning DoseActive Control1 Intervention
We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the morning and a placebo pill in the evening for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.
Group IV: Valsartan Evening DoseActive Control1 Intervention
We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the evening and a placebo pill in the morning for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.
Find a site
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,508 Previous Clinical Trials
2,256,401 Total Patients Enrolled
Pankaj Arora, MD, FAHAPrincipal Investigator
University of Alabama at Birmingham4 Previous Clinical Trials
924 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still looking for more participants for this experiment?
"The trial is still recruiting patients, according to the clinicaltrials.gov listing. The posting went up on February 18th, 2022 and was edited as recently as October 14th of the same year."
Answered by AI
Are there any other ongoing research projects studying Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet?
"There are currently 39 ongoing clinical trials studying the efficacy of Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet. Of those, 8 are large Phase 3 trials. The majority of these studies are taking place in Montreal, Quebec; however, there are a total of 812 research sites worldwide."
Answered by AI
What is the therapeutic target for Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet?
"The ventricular dysfunction, left can often be treated by taking Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet. This medication is also able to help patients that are struggling with essential hypertension or have a history of cardiovascular events."
Answered by AI
How many people are being enrolled in this clinical trial?
"You are correct, the trial is still recruiting patients. The information on clinicaltrials.gov shows that the trial was posted on 2/18/2022 and updated on 10/14/2022. Currently, they are looking to enroll 160 patients from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Alabama
How old are they?
< 18
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
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