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A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00779181
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : December 17, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: ADX415 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension
Study Start Date : October 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: ADX415 (high dose)
A high dose of ADX415
Drug: ADX415
ADX415 taken three times a day to achieve a high total daily dose
Experimental: ADX415 (mid level dose)
A mid level dose of ADX415
Drug: ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
Experimental: ADX415 (low dose)
A low dose of ADX415
Drug: ADX415
ADX415 taken three times a day to achieve a low total daily dose
Placebo Comparator: Placebo Drug: Placebo
Placebo taken three times a day


Outcome Measures

Primary Outcome Measures :
  1. Change in ABPM measures [ Time Frame: Baseline to Day 26 ]

Secondary Outcome Measures :
  1. Treatment emergent adverse events, lab tests, vitals signs, and ECGs [ Time Frame: Throughout treatment period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate hypertension
  • Age 18-75 years, inclusive

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779181


Locations
United States, Texas
Austin, Texas, United States, 78704
Austin, Texas, United States, 78759
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Addrenex Pharmaceuticals, Inc.
Investigators
Study Director: Moise Khayrallah, PhD Addrenex Pharmaceuticals, Inc.
More Information

Responsible Party: Moise Khayrallah, PhD / President and CEO, Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00779181     History of Changes
Other Study ID Numbers: ADX415-301
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008

Keywords provided by Addrenex Pharmaceuticals, Inc.:
Hypertension
High blood pressure
Htn
Addrenex

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases