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

This study has been completed.
Sponsor:
Information provided by:
Arete Therapeutics
ClinicalTrials.gov Identifier:
NCT00847899
First received: February 17, 2009
Last updated: November 18, 2009
Last verified: November 2009

February 17, 2009
November 18, 2009
January 2009
October 2009   (final data collection date for primary outcome measure)
  • Systolic and Diastolic blood pressure [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]
  • Glucose dynamics and insulin sensitivity [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00847899 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Impaired Glucose Tolerance
  • Drug: AR9281
    AR9281 taken in BID dosing regimen for 28 days
  • Drug: AR9281
    AR9281 taken in TID dosing regimen for 28 days
  • Drug: Placebo
    Placebo taken in BID dosing regimen for 28 days
  • Drug: Placebo
    Placebo taken in TID dosing regimen for 28 days
  • Active Comparator: 1
    AR9281
    Intervention: Drug: AR9281
  • Active Comparator: 2
    AR9281
    Intervention: Drug: AR9281
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
November 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00847899
AR9281-CLN-003
No
Calvert Lee, Sr. CRA, Arete Therapeutics
Arete Therapeutics
Not Provided
Not Provided
Arete Therapeutics
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP