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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 (Responsible Party):
Egalet Ltd
ClinicalTrials.gov Identifier:
NCT00444834
First received: March 7, 2007
Last updated: August 26, 2016
Last verified: August 2016
  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:


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 ] [ 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 ]

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
Coreg
Drug: Carvedilol
50 mg

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT00444834

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

Responsible Party: Egalet Ltd
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: August 26, 2016
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
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on September 27, 2016