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

Addrenex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: ADX415; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00779181

ADX415-301

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

ADX415 (high dose)

Experimental group

Description:

A high dose of ADX415

Treatment:

Drug: ADX415

Drug: ADX415

Drug: ADX415

ADX415 (mid level dose)

Experimental group

Description:

A mid level dose of ADX415

Treatment:

Drug: ADX415

Drug: ADX415

Drug: ADX415

ADX415 (low dose)

Experimental group

Description:

A low dose of ADX415

Treatment:

Drug: ADX415

Drug: ADX415

Drug: ADX415

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo