Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)

NCT00662116 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2009-01-30

No results posted yet for this study

Summary

This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.

Conditions

  • Diastolic Heart Failure

Interventions

DRUG

alagebrium

200 mg (two 100 mg tablets) two times daily for 24 weeks

DRUG

placebo

placebo tablets - two tablets taken twice daily

Sponsors & Collaborators

  • Synvista Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Bertram Pitt, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-10-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662116 on ClinicalTrials.gov