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Sponsored by: |
Addrenex Pharmaceuticals, Inc. |
---|---|
Information provided by: | Addrenex Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00779181 |
The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: ADX415 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension |
Enrollment: | 80 |
Study Start Date: | October 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ADX415 (high dose): Experimental
A high dose of ADX415
|
Drug: ADX415
ADX415 taken three times a day to achieve a high total daily dose
|
ADX415 (mid level dose): Experimental
A mid level dose of ADX415
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Drug: ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
|
ADX415 (low dose): Experimental
A low dose of ADX415
|
Drug: ADX415
ADX415 taken three times a day to achieve a low total daily dose
|
Placebo: Placebo Comparator |
Drug: Placebo
Placebo taken three times a day
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Austin, Texas, United States, 78704 | |
Austin, Texas, United States, 78759 | |
San Antonio, Texas, United States, 78217 |
Study Director: | Moise Khayrallah, PhD | Addrenex Pharmaceuticals, Inc. |
Responsible Party: | Addrenex Pharmaceuticals, Inc. ( Moise Khayrallah, PhD / President and CEO ) |
Study ID Numbers: | ADX415-301 |
Study First Received: | October 23, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00779181 |
Health Authority: | United States: Food and Drug Administration |
Hypertension High blood pressure Htn Addrenex |
Vascular Diseases Essential hypertension Hypertension |
Cardiovascular Diseases |