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NCT00038077 Clinical Trial

Reversal of Ventricular Remodeling With Toprol-XL

Heart Failure, Congestive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038077
Other study ID # 276
Secondary ID USMET0002
Status Completed
Phase Phase 3
First received May 28, 2002
Last updated November 17, 2010
Start date August 2001
Est. completion date September 2003

Study information
Verified date November 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date September 2003
Est. primary completion date September 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Seloken ZOK/Toprol-XL
50 mg
• Seloken ZOK/Toprol-XL
200 mg
• Placebo

Locations
Country Name City State
United States Research Site Farmington Connecticut

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

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