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

Sponsored by:	Addrenex Pharmaceuticals, Inc.
Information provided by:	Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00779181

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 II

MedlinePlus related topics: High Blood Pressure

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

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
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	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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

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

Keywords provided by Addrenex Pharmaceuticals, Inc.:

Hypertension
High blood pressure
Htn
Addrenex

Study placed in the following topic categories:

Vascular Diseases
Essential hypertension
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009