Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome (AMORE Trial)

Phase 4

Waitlist Available

Led By Bobby V Khan, MD, PhD

Research Sponsored by InVasc Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 weeks

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Summary

The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.

Eligible Conditions

High Blood Pressure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Central Aortic Pressure (CAP)

Secondary study objectives

Blood pressure control

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

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.

Trial Design

2Treatment groups

Active Control

Group I: Azor-Treatment AActive Control1 Intervention

Weeks 1-2: Azor® 5/20 Weeks 3-14: Azor® 10/40 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily

Group II: Hyzaar-Treatment Arm BActive Control1 Intervention

Weeks 1-2: Hyzaar® 50/12.5 Weeks 3-14: Hyzaar® 100/25 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily

Do I qualify?Apply below to find out