A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension
NCT ID: NCT00779181
Last Updated: 2008-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2008-10-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ADX415 (high dose)
A high dose of ADX415
ADX415
ADX415 taken three times a day to achieve a high total daily dose
ADX415 (mid level dose)
A mid level dose of ADX415
ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
ADX415 (low dose)
A low dose of ADX415
ADX415
ADX415 taken three times a day to achieve a low total daily dose
Placebo
Placebo
Placebo taken three times a day
Interventions
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ADX415
ADX415 taken three times a day to achieve a high total daily dose
ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
ADX415
ADX415 taken three times a day to achieve a low total daily dose
Placebo
Placebo taken three times a day
Eligibility Criteria
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Inclusion Criteria
* Age 18-75 years, inclusive
Exclusion Criteria
* Current treatment with 3 or more antihypertensive meds
* Presence of Type I or uncontrolled Type II diabetes
* Presence of alcohol or drug abuse
18 Years
75 Years
ALL
No
Sponsors
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Addrenex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Addrenex Pharmaceuticals, Inc.
Principal Investigators
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Moise Khayrallah, PhD
Role: STUDY_DIRECTOR
Addrenex Pharmaceuticals, Inc.
Locations
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Austin, Texas, United States
Austin, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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ADX415-301
Identifier Type: -
Identifier Source: org_study_id