Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444834
Recruitment Status : Terminated (IMP supply)
First Posted : March 8, 2007
Last Update Posted : August 29, 2016
Information provided by (Responsible Party):
Egalet Ltd

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Carvedilol Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Egalet carvedilol
Drug: Carvedilol
50 mg

Active Comparator: 2
Drug: Carvedilol
50 mg

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Safety [ Time Frame: 15w ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444834

Layout table for location information
Site 02
Esbjerg, Denmark
Site 01
Frederiksberg, Denmark
Sponsors and Collaborators
Egalet Ltd
Layout table for investigator information
Study Director: Christine Andersen, MSc Pharm Egalet A/S

Layout table for additonal information
Responsible Party: Egalet Ltd Identifier: NCT00444834     History of Changes
Other Study ID Numbers: CL-EG-006
EudraCT no.: 2006-006534-17
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists