Back to resultsA Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
Primary Purpose
Hypertension
Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Carvedilol
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
- Site 02
- Site 01
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Egalet carvedilol
Coreg
Outcomes
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
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
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444834
Brief Title
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
IMP supply
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egalet Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Egalet carvedilol
Arm Title
2
Arm Type
Active Comparator
Arm Description
Coreg
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
50 mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Safety
Time Frame
15w
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Andersen, MSc Pharm
Organizational Affiliation
Egalet A/S
Official's Role
Study Director
Facility Information:
Facility Name
Site 02
City
Esbjerg
Country
Denmark
Facility Name
Site 01
City
Frederiksberg
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
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