Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013