HypertensionPhase 2NCT00779181
A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension
A Phase 2 study testing ADX415 in people with Hypertension, run by Addrenex Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ADX415
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Dec 2008
- 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
- Age 18-75 years, inclusive
Who cannot join
- Clinically significant illnesses or abnormalities upon evaluation
- Current treatment with 3 or more antihypertensive meds
- Presence of Type I or uncontrolled Type II diabetes
- Presence of alcohol or drug abuse
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Austin, Texas, 78704
Study site
Austin, Texas, 78759
Study site
San Antonio, Texas, 78217
About this study
Official title: A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension
The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.
- Conditions
- Hypertension
- Being tested
- ADX415, Placebo
- Keywords
- Hypertension, High blood pressure, Htn, Addrenex
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX415Drug
ADX415 taken three times a day to achieve a high total daily dose
ADX415Drug
ADX415 taken three times a day to achieve a mid level total daily dose
ADX415Drug
ADX415 taken three times a day to achieve a low total daily dose
PlaceboDrug
Placebo taken three times a day
| Study group | Role | What they receive |
|---|---|---|
| ADX415 (high dose) | Experimental | A high dose of ADX415 Receives: Drug: ADX415 |
| ADX415 (mid level dose) | Experimental | A mid level dose of ADX415 Receives: Drug: ADX415 |
| ADX415 (low dose) | Experimental | A low dose of ADX415 Receives: Drug: ADX415 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ABPM measures
Measured: Baseline to Day 26
Secondary outcomes (1)
Treatment emergent adverse events, lab tests, vitals signs, and ECGs
Measured: Throughout treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addrenex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Moise Khayrallah, PhD, Study director, Addrenex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779181
- Sponsor's protocol ID
- ADX415-301
- Status last verified
- Dec 2008
- First submitted
- 23 Oct 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension
- ClinicalTrials.gov ID
- NCT00779181
- Acronym / sponsor ID
- ADX415-301
- Conditions
- Hypertension
- Keywords
- Hypertension, High blood pressure, Htn, Addrenex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Addrenex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Oct 2008 (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 a safe and effective dose of ADX415 for the treatment of hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADX415 (high dose) | Experimental | Drug: ADX415A high dose of ADX415 |
| ADX415 (mid level dose) | Experimental | Drug: ADX415A mid level dose of ADX415 |
| ADX415 (low dose) | Experimental | Drug: ADX415A low dose of ADX415 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate hypertension
- Age 18-75 years, inclusive
Key exclusion criteria (4 listed)
- Clinically significant illnesses or abnormalities upon evaluation
- Current treatment with 3 or more antihypertensive meds
- Presence of Type I or uncontrolled Type II diabetes
- Presence of alcohol or drug abuse
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 |
|---|---|---|
| ADX415ADX415 taken three times a day to achieve a high total daily dose | Drug | ADX415 (high dose) |
| ADX415ADX415 taken three times a day to achieve a mid level total daily dose | Drug | ADX415 (mid level dose) |
| ADX415ADX415 taken three times a day to achieve a low total daily dose | Drug | ADX415 (low dose) |
| PlaceboPlacebo taken three times a day | Drug | Placebo |
Primary outcome
Change in ABPM measures
Time frame: Baseline to Day 26
1 secondary outcome
Treatment emergent adverse events, lab tests, vitals signs, and ECGs
Time frame: Throughout 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 17 Dec 2008.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Moise Khayrallah, PhD study director
Addrenex Pharmaceuticals, Inc.
3 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 ADX415 in people with Hypertension, run by Addrenex Pharmaceuticals, Inc. at 3 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 2 inclusion and 4 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 17 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change in ABPM measures (time frame: Baseline to Day 26). 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 17 Dec 2008.