The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease...
Date First Received: May 28, 2002
Last Updated: June 10, 2009
Verified by: AstraZeneca, June 2009
Clinical Trial Phase: Phase 3 | Start Date: August 2001
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Toprol-XL 50 mg
- Drug: Toprol-XL 200 mg
- Drug: Placebo
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of stable asymptomatic heart failure.
- Documented ejection fraction less than 0.40.
- Must be able to comply with all study procedures.
Exclusion Criteria:
- Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization.
- Have heart problems that would not allow B-blocker therapy.
- Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma).
- Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty.
- Have certain heart diseases.
- Pregnant or breast feeding.
- Unlikely to survive.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00038077
Study ID Number: 276
ClinicalTrials.gov Identifier: NCT00038077
Health Authority: United States: Food and Drug Administration
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