NCT00779181

Brief Summary

The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 17, 2008

Status Verified

December 1, 2008

Enrollment Period

2 months

First QC Date

October 23, 2008

Last Update Submit

December 16, 2008

Conditions

Hypertension

Keywords

HypertensionHigh blood pressureHtnAddrenex

Outcome Measures

Primary Outcomes (1)

  • Change in ABPM measures

    Baseline to Day 26

Secondary Outcomes (1)

  • Treatment emergent adverse events, lab tests, vitals signs, and ECGs

    Throughout treatment period

Study Arms (4)

ADX415 (high dose)

EXPERIMENTAL

A high dose of ADX415

Drug: ADX415

ADX415 (mid level dose)

EXPERIMENTAL

A mid level dose of ADX415

Drug: ADX415

ADX415 (low dose)

EXPERIMENTAL

A low dose of ADX415

Drug: ADX415

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ADX415DRUG

ADX415 taken three times a day to achieve a high total daily dose

ADX415 (high dose)
PlaceboDRUG

Placebo taken three times a day

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Austin, Texas, 78704, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Moise Khayrallah, PhD

    Addrenex Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 17, 2008

Record last verified: 2008-12

Locations

US(3)