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

This study has been terminated.
(IMP supply)
Sponsor:
Information provided by:
Egalet a/s
ClinicalTrials.gov Identifier:
NCT00444834
First received: March 7, 2007
Last updated: February 12, 2008
Last verified: February 2008
History of Changes
  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 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:

Drug Information available for: Carvedilol
U.S. FDA Resources

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
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 02
Esbjerg, Denmark
Site 01
Frederiksberg, 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
ClinicalTrials.gov 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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 16, 2013