A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
- Registration Number
- NCT00444834
- Lead Sponsor
- Egalet Ltd
- Brief Summary
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
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
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Exclusion Criteria
- Be intolerant to alfa- or beta-blockers
- Have secondary causes of hypertension
- Be taking more than two antihypertensive medications
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Carvedilol Egalet carvedilol 2 Carvedilol Coreg
- Primary Outcome Measures
Name Time Method The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise 15w
- Secondary Outcome Measures
Name Time Method The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise 15w Safety 15w
Trial Locations
- Locations (2)
Site 02
🇩🇰Esbjerg, Denmark
Site 01
🇩🇰Frederiksberg, Denmark