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

March 7, 2007
February 12, 2008
April 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise
Complete list of historical versions of study NCT00444834 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise
  • Safety
Not Provided
Not Provided
 
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
Drug: Carvedilol
50 mg
  • Experimental: 1
    Egalet carvedilol
    Intervention: Drug: Carvedilol
  • Active Comparator: 2
    Coreg
    Intervention: Drug: Carvedilol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00444834
CL-EG-006, EudraCT no.: 2006-006534-17
No
Egalet a/s
Egalet a/s
Not Provided
Study Director: Christine Andersen, MSc Pharm Egalet a/s
Egalet a/s
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP