HypertensionPhase 2NCT00847899
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
A Phase 2 study testing AR9281 in people with Hypertension and Impaired Glucose Tolerance, run by Arete Therapeutics at 30 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Impaired Glucose Tolerance
- What is being tested?
- AR9281
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 30 sitesUnited States
- Study dates
- Jan 2009to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate hypertension
- naive to antihypertensive medication or on two or less antihypertensive medications
- impaired glucose tolerance
- mild obesity
Who cannot join
- Diagnosis of Type 1 or Type 2 diabetes
- History of severe heart failure
- AST, ALT levels more than twice the normal range
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Arete Investigational site
Addison, Illinois, 60101
Arete Investigational site
Anaheim, California, 92801
Arete Investigational site
Austin, Texas, 78704
Arete Investigational site
Bradenton, Florida, 34203
Arete Investigational site
Brockton, Massachusetts, 02301
Arete Investigational site
Cincinnati, Ohio, 45219
Arete Investigational site
Cincinnati, Ohio, 45245
Arete Investigational site
Concord, California, 94520
Arete Investigational site
Dallas, Texas, 75251
Arete Investigational site
DeLand, Florida, 32720
Arete Investigational site
Eugene, Oregon, 97404
Arete Investigational site
Jacksonville, Florida, 32216
Arete Investigational site
Largo, Florida, 33770
Arete Investigational site
Las Vegas, Nevada, 89123
Arete Investigational site
Louisville, Kentucky, 40213
Arete Investigational site
Marietta, Georgia, 30066
Arete Investigational site
Marion, Ohio, 43302
Arete Investigational site
Miami, Florida, 33169
Arete Investigational site
Mission Hills, California, 91345
Arete Investigational site
Mobile, Alabama, 36617
Arete investigational site
Mount Gilead, Ohio, 43338
Arete Investigational site
Muscle Shoals, Alabama, 35662
Arete Investigational site
New Port Richey, Florida, 34652
Arete Investigational site
Oklahoma City, Oklahoma, 73132
Arete Investigational site
Orem, Utah, 84058
Arete Investigational site
Paw Paw, Michigan, 49079
Arete Investigational site
Pembroke Pines, Florida, 33026
Arete Investigational site
Port Orange, Florida, 32127
Arete Investigational site
San Antonio, Texas, 78229
Arete Investigational site
Tampa, Florida, 33606
About this study
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
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.
- Conditions
- Hypertension, Impaired Glucose Tolerance
- Being tested
- AR9281, Placebo
- Keywords
- hypertension, impaired glucose tolerance, s-EH enzyme inhibition, pre-diabetes
- Medical subject headings
- Hypertension, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR9281Drug
AR9281 taken in BID dosing regimen for 28 days
AR9281Drug
AR9281 taken in TID dosing regimen for 28 days
PlaceboDrug
Placebo taken in BID dosing regimen for 28 days
PlaceboDrug
Placebo taken in TID dosing regimen for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AR9281 Receives: Drug: AR9281 |
| 2 | Active comparator | AR9281 Receives: Drug: AR9281 |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic blood pressure
Measured: 28 day treatment period
Glucose dynamics and insulin sensitivity
Measured: 28 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arete Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847899
- Sponsor's protocol ID
- AR9281-CLN-003
- Status last verified
- Nov 2009
- First submitted
- 17 Feb 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00847899
- Acronym / sponsor ID
- AR9281-CLN-003
- Conditions
- Hypertension, Impaired Glucose Tolerance
- Keywords
- hypertension, impaired glucose tolerance, s-EH enzyme inhibition, pre-diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Arete TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AR9281AR9281 |
| 2 | Active comparator | Drug: AR9281AR9281 |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mild to moderate hypertension
- naive to antihypertensive medication or on two or less antihypertensive medications
- impaired glucose tolerance
- mild obesity
Key exclusion criteria (3 listed)
- Diagnosis of Type 1 or Type 2 diabetes
- History of severe heart failure
- AST, ALT levels more than twice the normal range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR9281AR9281 taken in BID dosing regimen for 28 days | Drug | 1 |
| AR9281AR9281 taken in TID dosing regimen for 28 days | Drug | 2 |
| PlaceboPlacebo taken in BID dosing regimen for 28 days | Drug | 3 |
| PlaceboPlacebo taken in TID dosing regimen for 28 days | Drug | 4 |
Primary outcome
Systolic and Diastolic blood pressure
Time frame: 28 day treatment period
Glucose dynamics and insulin sensitivity
Time frame: 28 day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
- Arete Therapeutics home websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR9281 in people with Hypertension and Impaired Glucose Tolerance, run by Arete Therapeutics at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic blood pressure (time frame: 28 day treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.