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NCT00444834 Clinical Trial

A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00444834
Other study ID # CL-EG-006
Secondary ID EudraCT no.: 200
Status Terminated
Phase Phase 2
First received March 7, 2007
Last updated August 26, 2016
Start date April 2007
Est. completion date May 2007

Study information
Verified date August 2016
Source Egalet Ltd
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Carvedilol
50 mg

Locations
Country Name City State
Denmark Site 02 Esbjerg
Denmark Site 01 Frederiksberg

Sponsors (1)
Lead Sponsor Collaborator
Egalet Ltd

Country where clinical trial is conducted

Denmark, 

Outcome
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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