This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
(IMP supply)
Information provided by (Responsible Party):
Egalet Ltd Identifier:
First received: March 7, 2007
Last updated: August 26, 2016
Last verified: August 2016
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.

Condition Intervention Phase
Hypertension Drug: Carvedilol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Egalet Ltd:

Primary Outcome 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 ]

Secondary Outcome 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 [ Time Frame: 15w ]

Enrollment: 14
Study Start Date: April 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Egalet carvedilol
Drug: Carvedilol
50 mg
Active Comparator: 2
Drug: Carvedilol
50 mg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00444834

Site 02
Esbjerg, Denmark
Site 01
Frederiksberg, Denmark
Sponsors and Collaborators
Egalet Ltd
Study Director: Christine Andersen, MSc Pharm Egalet A/S
  More Information

Responsible Party: Egalet Ltd Identifier: NCT00444834     History of Changes
Other Study ID Numbers: CL-EG-006
EudraCT no.: 2006-006534-17
Study First Received: March 7, 2007
Last Updated: August 26, 2016

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists processed this record on September 21, 2017