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Sacubitril-Valsartan + Valsartan for Prediabetes, Diabetes, Obesity, and High Blood Pressure

The Ohio State University Wexner Medical Center, Columbus, OH

Targeting 4 different conditionsSacubitril-Valsartan Tab 97-103 MG +2 morePhase 4Waitlist AvailableLed by Joshua J Joseph, MDResearch Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up26 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Study Summary

This trial is testing whether two drugs, valsartan and sacubitril, can improve blood sugar and insulin secretion better than valsartan alone in African Americans with impaired glucose tolerance.

Eligible Conditions

Obesity
Prediabetes
High Blood Pressure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Structure of beta Cell of islet

Secondary outcome measures

Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks

Awards & Highlights

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.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Sacubitril/ValsartanExperimental Treatment1 Intervention

Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks

Group II: ValsartanActive Control1 Intervention

Valsartan 160 mg twice daily for 26 weeks

Group III: PlaceboPlacebo Group1 Intervention

placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

792 Previous Clinical Trials

458,983 Total Patients Enrolled

22 Trials studying Obesity

3,801 Patients Enrolled for Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,296 Previous Clinical Trials

4,211,838 Total Patients Enrolled

432 Trials studying Obesity

497,318 Patients Enrolled for Obesity

Joshua J Joseph, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center

2 Previous Clinical Trials

172 Total Patients Enrolled

Media Library

Placebo Oral Tablet Clinical Trial Eligibility Overview. Trial Name: NCT03938389 — Phase 4

Obesity Research Study Groups: Valsartan, Sacubitril/Valsartan, Placebo

Obesity Clinical Trial 2023: Placebo Oral Tablet Highlights & Side Effects. Trial Name: NCT03938389 — Phase 4

Placebo Oral Tablet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938389 — Phase 4

Frequently Asked Questions

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

Could you please elaborate on other research conducted regarding Sacubitril-Valsartan Tab 97-103 MG?

"At present, there are 37 active clinical trials investigating the potential of Sacubitril-Valsartan Tab 97-103 MG with 8 in Phase 3. Montreal, Quebec is home to a majority of these studies but they can also be found at numerous other medical centres across North America (826 sites)."

Answered by AI

Has the Federal Drug Administration given sanction to Sacubitril-Valsartan Tab 97-103 MG?

"The safety of Sacubitril-Valsartan Tab 97-103 MG is rated at a 3 due to the completion of Phase 4 trials and its official approval."

Answered by AI

What medical conditions is Sacubitril-Valsartan Tab 97-103 MG most commonly employed to address?

"Sacubitril-Valsartan Tab 97-103 MG is regularly prescribed for the treatment of left ventricular dysfunction. Beyond this, it can be useful in addressing essential hypertension that hasn't responded to monotherapy and preventing cardiovascular l hypertension that hasn't responded to monotherapy and preventing cardiovascular incident."

Answered by AI

What is the maximum capacity of participants for this clinical investigation?

"Affirmative. According to the info on clinicaltrials.gov, this medical trial is currently open for recruitment and was initially posted on February 25th 2020. It's looking to enroll 90 patients from a single site with its last update occurring in July 2021."

Answered by AI

Who is eligible to take part in this research project?

"To qualify for this experiment, potential participants must display signs of impaired glucose tolerance and be between 18-65 years old. Presently, the study is aiming to recruit around 90 individuals."

Answered by AI

Is this research endeavor welcoming individuals over the age of 35?

"This clinical research is open to participants aged between 18 and 65. Separately, there are 216 trials available for minors and 853 studies suitable for patients above the age of majority."

Answered by AI

Is it still possible to enrol in this medical experiment?

"Affirmative. According to the data on clinicaltrials.gov, this experiment is currently seeking participants; it was first announced on February 25th 2020 and last revised in July 21st 2022. The research requires 90 people across a single medical institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans

Joshua Joseph, MD 2020. "The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03938389.

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