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

Condition(s) targeted: Hypertension

Intervention: Carvedilol (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Egalet a/s

Official(s) and/or principal investigator(s):
Christine Andersen, MSc Pharm, Study Director, Affiliation: Egalet a/s

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study

Primary outcome: The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise

Secondary outcome:

The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise

Safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Site 01, Frederiksberg, Denmark

Site 02, Esbjerg, Denmark

Starting date: April 2007
Ending date: October 2007
Last updated: February 12, 2008