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”

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

Study Type: Interventional

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

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: Carvedilol
  • 50 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Egalet carvedilol
• Active Comparator: 2
  • Coreg

Primary Measures

• The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise
  • Time Frame: 15w
    Safety Issue?: No

Secondary Measures

• The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise
  • Time Frame: 15w
    Safety Issue?: No
• Safety
  • Time Frame: 15w
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Egalet a/s

Overall Clinical Trial Officials and Contacts

Christine Andersen, MSc Pharm Study Director Egalet a/s  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00444834

Study ID Number: CL-EG-006

ClinicalTrials.gov Identifier: NCT00444834

Health Authority: Denmark: Danish Medicines Agency