NCT00739687

Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure

A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Synvista Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	ALT-711	200 mg tablet BID for 9 months.
DRUG	Placebo	200 mg tablet BID for 9 months.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2009-10-01
• First posted: 2008-08-22
• Last updated: 2009-01-30

Locations

4 sites across 1 country: United States