Status:
COMPLETED
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
Lead Sponsor:
Cardiovascular Clinical Sciences Inc
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a...
Detailed Description
Study Further Study Details: Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed) Expected Total Enrollment: 400 subjects at 56 study sites in the U.S. Study St...
Eligibility Criteria
Inclusion
- Ability to read English
- Stable symptoms of mild to severe heart failure
- Stable medical regimen for heart failure
- On a stable dose of Coreg for at least 2 months
- LVEF ≤40% within the previous 24 months
Exclusion
- Uncorrected obstructive or regurgitant valve disease
- Complex congenital heart disease
- Recent ICD or pacemaker placement
- Recent coronary artery bypass surgery or stroke
- Candidate for heart transplanct within 5 months of study start
- Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00272805
Start Date
October 1 2005
End Date
July 1 2006
Last Update
February 18 2013
Active Locations (54)
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1
The Heart Group
Mobile, Alabama, United States, 36608
2
Radiant Research
Sierra Vista, Arizona, United States, 85635
3
Cardiology Consultants of Orange County
Anaheim, California, United States, 92801
4
Access Clinical Trials
Beverly Hills, California, United States, 90210