Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Egalet a/s Identifier:
First received: March 7, 2007
Last updated: February 12, 2008
Last verified: February 2008

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
Drug: Carvedilol
Phase 2

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
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 a/s:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 15w ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: October 2007
Estimated Primary Completion Date: October 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
Genders Eligible for Study:   Both
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 a/s
Study Director: Christine Andersen, MSc Pharm Egalet a/s
  More Information

No publications provided

Responsible Party: Egalet a/s 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: February 12, 2008
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on March 01, 2015