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

This study has been terminated.

( IMP supply )

First Received: March 7, 2007 Last Updated: February 12, 2008 History of Changes

Sponsored by:	Egalet a/s
Information provided by:	Egalet a/s
ClinicalTrials.gov Identifier:	NCT00444834

Purpose

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 II

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

Drug Information available for: Carvedilol

U.S. FDA Resources

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

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
1: Experimental Egalet carvedilol	Drug: Carvedilol 50 mg
2: Active Comparator Coreg	Drug: Carvedilol 50 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444834

Locations

Denmark
Site 01
Frederiksberg, Denmark
Site 02
Esbjerg, Denmark

Sponsors and Collaborators

Egalet a/s

Investigators

Study Director:

Christine Andersen, MSc Pharm

Egalet a/s

More Information

No publications provided

Responsible Party:	Egalet a/s ( Egalet a/s )
Study ID Numbers:	CL-EG-006, EudraCT no.: 2006-006534-17
Study First Received:	March 7, 2007
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00444834 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Essential Hypertension
Adrenergic Agents
Vascular Diseases
Adrenergic beta-Antagonists

Adrenergic Antagonists
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Carvedilol
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on May 06, 2009