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

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ClinicalTrials.gov Identifier: NCT00847899
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Arete Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Impaired Glucose Tolerance Drug: AR9281 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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



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


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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

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

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 Posted: February 19, 2009    Key Record Dates
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