A Dose-Ranging Study of the Safety and Efficacy of ADX415... | NCT00779181

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

NCT00779181

Sponsor

Addrenex Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Dec 17, 2008Estimated

Enrollment

80Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

ADX415
ADX415
ADX415
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 23, 2008

First Submission Date that Met QC Criteria

Oct 23, 2008

First Posted Date

Oct 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2008

Last Update Posted Date

Dec 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ADX415	Drug	ADX415 taken three times a day to achieve a high total daily dose	ADX415 (high dose)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in ABPM measures		Baseline to Day 26

Secondary Outcomes

Measure	Description	Time Frame
Treatment emergent adverse events, lab tests, vitals signs, and ECGs		Throughout treatment period

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moise Khayrallah, PhD	Addrenex Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Austin	Texas	78704	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided