NCT00847899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

February 17, 2009

Last Update Submit

November 18, 2009

Conditions

HypertensionImpaired Glucose Tolerance

Keywords

hypertensionimpaired glucose tolerances-EH enzyme inhibitionpre-diabetes

Outcome Measures

Primary Outcomes (2)

  • Systolic and Diastolic blood pressure

    28 day treatment period

  • Glucose dynamics and insulin sensitivity

    28 day treatment period

Study Arms (4)

1

ACTIVE COMPARATOR

AR9281

Drug: AR9281

2

ACTIVE COMPARATOR

AR9281

Drug: AR9281

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AR9281DRUG

AR9281 taken in BID dosing regimen for 28 days

1
PlaceboDRUG

Placebo taken in BID dosing regimen for 28 days

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to moderate hypertension
  • naive to antihypertensive medication or on two or less antihypertensive medications
  • impaired glucose tolerance
  • mild obesity

You may not qualify if:

  • Diagnosis of Type 1 or Type 2 diabetes
  • History of severe heart failure
  • AST, ALT levels more than twice the normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Arete Investigational site

Mobile, Alabama, 36617, United States

Location

Arete Investigational site

Muscle Shoals, Alabama, 35662, United States

Location

Arete Investigational site

Anaheim, California, 92801, United States

Location

Arete Investigational site

Concord, California, 94520, United States

Location

Arete Investigational site

Mission Hills, California, 91345, United States

Location

Arete Investigational site

Bradenton, Florida, 34203, United States

Location

Arete Investigational site

DeLand, Florida, 32720, United States

Location

Arete Investigational site

Jacksonville, Florida, 32216, United States

Location

Arete Investigational site

Largo, Florida, 33770, United States

Location

Arete Investigational site

Miami, Florida, 33169, United States

Location

Arete Investigational site

New Port Richey, Florida, 34652, United States

Location

Arete Investigational site

Pembroke Pines, Florida, 33026, United States

Location

Arete Investigational site

Port Orange, Florida, 32127, United States

Location

Arete Investigational site

Tampa, Florida, 33606, United States

Location

Arete Investigational site

Marietta, Georgia, 30066, United States

Location

Arete Investigational site

Addison, Illinois, 60101, United States

Location

Arete Investigational site

Louisville, Kentucky, 40213, United States

Location

Arete Investigational site

Brockton, Massachusetts, 02301, United States

Location

Arete Investigational site

Paw Paw, Michigan, 49079, United States

Location

Arete Investigational site

Las Vegas, Nevada, 89123, United States

Location

Arete Investigational site

Cincinnati, Ohio, 45219, United States

Location

Arete Investigational site

Cincinnati, Ohio, 45245, United States

Location

Arete Investigational site

Marion, Ohio, 43302, United States

Location

Arete investigational site

Mount Gilead, Ohio, 43338, United States

Location

Arete Investigational site

Oklahoma City, Oklahoma, 73132, United States

Location

Arete Investigational site

Eugene, Oregon, 97404, United States

Location

Arete Investigational site

Austin, Texas, 78704, United States

Location

Arete Investigational site

Dallas, Texas, 75251, United States

Location

Arete Investigational site

San Antonio, Texas, 78229, United States

Location

Arete Investigational site

Orem, Utah, 84058, United States

Location

Related Links

MeSH Terms

Conditions

HypertensionGlucose Intolerance

Interventions

1-(1-acetyl-piperidine-4-yl)-3-adamantan-1-yl-urea

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 19, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations

US(30)