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

Verified by: Egalet a/s, February 2008
First Received: March 7, 2007 | Last Updated: February 12, 2008 | Phase: Phase 2 | Start Date: April 2007
Overall Status: Terminated | Estimated Enrollment: 40
  • …
  • Tell a FriendPrint

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

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Egalet a/s Industry

Overall Clinical Trial Officials and Contacts

Christine Andersen, MSc Pharm Study Director Egalet a/s  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00444834

  • Conditions

  • Intervention(s):

  • Condition MeSH Term(s), Assigned with an Experimental Algorithm

  • Intervention MeSH Term(s), Assigned with an Experimental Algorithm