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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:
ClinicalTrials.gov Identifier:
NCT00847899
First Posted: February 19, 2009
Last Update Posted: November 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Arete Therapeutics
  Purpose
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.

Condition Intervention Phase
Hypertension Impaired Glucose Tolerance Drug: AR9281 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Arete Therapeutics:

Primary Outcome Measures:
  • Systolic and Diastolic blood pressure [ Time Frame: 28 day treatment period ]
  • Glucose dynamics and insulin sensitivity [ Time Frame: 28 day treatment period ]

Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AR9281
Drug: AR9281
AR9281 taken in BID dosing regimen for 28 days
Active Comparator: 2
AR9281
Drug: AR9281
AR9281 taken in TID dosing regimen for 28 days
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo taken in BID dosing regimen for 28 days
Placebo Comparator: 4
Placebo
Drug: Placebo
Placebo taken in TID dosing regimen for 28 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847899


  Show 30 Study Locations
Sponsors and Collaborators
Arete Therapeutics
  More Information

Additional Information:
Responsible Party: Calvert Lee, Sr. CRA, Arete Therapeutics
ClinicalTrials.gov Identifier: NCT00847899     History of Changes
Other Study ID Numbers: AR9281-CLN-003
First Submitted: February 17, 2009
First Posted: February 19, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009

Keywords provided by Arete Therapeutics:
hypertension
impaired glucose tolerance
s-EH enzyme inhibition
pre-diabetes

Additional relevant MeSH terms:
Hypertension
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases


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