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

This study has been completed.
Sponsor:
Information provided by:
Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00779181
First received: October 23, 2008
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Addrenex Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in ABPM measures [ Time Frame: Baseline to Day 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment emergent adverse events, lab tests, vitals signs, and ECGs [ Time Frame: Throughout treatment period ] [ Designated as safety issue: Yes ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Moise Khayrallah, PhD / President and CEO, Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00779181     History of Changes
Other Study ID Numbers: ADX415-301
Study First Received: October 23, 2008
Last Updated: December 16, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014