Reversal of Ventricular Remodeling With Toprol-XL

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):

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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