A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension

A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension

The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.

Inclusion Criteria:

• Have a diagnosis of mild or moderate primary hypertension
• Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase
• Be minimum 18 years of age

Exclusion Criteria:

• Be intolerant to alfa- or beta-blockers
• Have secondary causes of hypertension
• Be taking more than two antihypertensive medications