Overview

This trial is active, not recruiting.

Condition hypertension
Treatments amlodipine and olmesartan, losartan and hctz
Phase phase 4
Sponsor InVasc Therapeutics, Inc.
Start date April 2010
End date June 2011
Trial size 80 participants
Trial identifier NCT01271374, AVR-2010-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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
losartan and hctz Hyzaar
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
(Active Comparator)
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
amlodipine and olmesartan Azor
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

Primary Outcomes

Measure
Change in Central Aortic Pressure (CAP)
time frame: 14 weeks

Secondary Outcomes

Measure
Blood pressure control
time frame: 25 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - African American - Hypertension and one of the following: - Fasting glucose > 100 mg/dl - HgA1C> 6.0 % - Plasma triglycerides >150 - HDL cholesterol < 40 mg/dl in men or < 50 mg/dl in women Exclusion Criteria: - History of Heart failure - use of insulin - non-dominant arm circ > 50 cm.

Additional Information

Official title Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan
Principal investigator Bobby V Khan, MD, PhD
Description Participants must be 18-75 years of age, African American, and have a combination of high blood pressure, insulin resistance (Type 2 Diabetes), low HDL cholesterol levels or obesity.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by InVasc Therapeutics, Inc..