Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT00847899
  4. Details
NCT00847899 Clinical Trial

Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Hypertension Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Exploratory, 28-Day Study to Examine the Effects of AR9281 on Blood Pressure and Glucose Tolerance in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00847899
Other study ID # AR9281-CLN-003
Secondary ID
Status Completed
Phase Phase 2
First received February 17, 2009
Last updated November 18, 2009
Start date January 2009
Est. completion date November 2009

Study information
Verified date November 2009
Source Arete Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- mild to moderate hypertension

- naive to antihypertensive medication or on two or less antihypertensive medications

- impaired glucose tolerance

- mild obesity

Exclusion Criteria:

- Diagnosis of Type 1 or Type 2 diabetes

- History of severe heart failure

- AST, ALT levels more than twice the normal range

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AR9281
AR9281 taken in BID dosing regimen for 28 days
• AR9281
AR9281 taken in TID dosing regimen for 28 days
• Placebo
Placebo taken in BID dosing regimen for 28 days
• Placebo
Placebo taken in TID dosing regimen for 28 days

Locations
Country Name City State
United States Arete Investigational site Addison Illinois
United States Arete Investigational site Anaheim California
United States Arete Investigational site Austin Texas
United States Arete Investigational site Bradenton Florida
United States Arete Investigational site Brockton Massachusetts
United States Arete Investigational site Cincinnati Ohio
United States Arete Investigational site Cincinnati Ohio
United States Arete Investigational site Concord California
United States Arete Investigational site Dallas Texas
United States Arete Investigational site Deland Florida
United States Arete Investigational site Eugene Oregon
United States Arete Investigational site Jacksonville Florida
United States Arete Investigational site Largo Florida
United States Arete Investigational site Las Vegas Nevada
United States Arete Investigational site Louisville Kentucky
United States Arete Investigational site Marietta Georgia
United States Arete Investigational site Marion Ohio
United States Arete Investigational site Miami Florida
United States Arete Investigational site Mission Hills California
United States Arete Investigational site Mobile Alabama
United States Arete investigational site Mt. Gilead Ohio
United States Arete Investigational site Muscle Shoals Alabama
United States Arete Investigational site New Port Richey Florida
United States Arete Investigational site Oklahoma City Oklahoma
United States Arete Investigational site Orem Utah
United States Arete Investigational site Paw Paw Michigan
United States Arete Investigational site Pembroke Pines Florida
United States Arete Investigational site Port Orange Florida
United States Arete Investigational site San Antonio Texas
United States Arete Investigational site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Arete Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic and Diastolic blood pressure 28 day treatment period No
Primary Glucose dynamics and insulin sensitivity 28 day treatment period No
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A

External Links