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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 September 2016 |
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Main ID: |
NCT00444834 |
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Date of registration:
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07/03/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
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Scientific title:
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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 |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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14 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00444834 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Christine Andersen, MSc Pharm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Egalet A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: Carvedilol
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Safety
[Time Frame: 15w]
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Secondary ID(s)
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CL-EG-006
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EudraCT no.: 2006-006534-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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