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

Egalet

Status and phase: Terminated; Phase 2

Conditions: Hypertension

Treatments: Drug: Carvedilol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444834

EudraCT no.: 2006-006534-17

CL-EG-006

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups

1

Experimental group

Description:

Egalet carvedilol

Treatment:

Drug: Carvedilol

2

Active Comparator group

Description:

Coreg

Treatment:

Drug: Carvedilol