Hypertension Clinical Trial
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
Verified date | August 2016 |
Source | Egalet Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.
Status | Terminated |
Enrollment | 14 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Site 02 | Esbjerg | |
Denmark | Site 01 | Frederiksberg |
Lead Sponsor | Collaborator |
---|---|
Egalet Ltd |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise | 15w | No | |
Secondary | The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise | 15w | No | |
Secondary | Safety | 15w | No |
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