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

This study has been terminated.
(Study has been terminated early due to financial constraints.)
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00662116
First received: April 17, 2008
Last updated: January 29, 2009
Last verified: January 2009

April 17, 2008
January 29, 2009
March 2008
October 2009   (final data collection date for primary outcome measure)
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test [ Time Frame: Assessed at baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662116 on ClinicalTrials.gov Archive Site
  • QOL as assessed by the Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • To assess New York Heart Association Classification [ Time Frame: Baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • To evaluate cardiovascular death or hospitalization for heart failure [ Time Frame: Will be assessed during the entire 24 wk trial ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diastolic Heart Failure
  • Drug: alagebrium
    200 mg (two 100 mg tablets) two times daily for 24 weeks
    Other Name: ALT-711
  • Drug: placebo
    placebo tablets - two tablets taken twice daily
    Other Name: placebo
  • Experimental: 1
    Intervention: Drug: alagebrium
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
December 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of diabetes or hypertension requiring therapy
  • EF >/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'>/= 12 determined by echo within 1 year
  • previous hospitalization for heart failure or previous BNP >100 pg/mL.

Exclusion Criteria:

  • Clinically significant valvular disease
  • history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
  • history of acute MI within 6 months
  • severe COPD
  • active or treated malignancies (except basal cell carcinoma)
  • significant systemic illnesses that would prohibit completion of the study or compliance
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662116
ALT-711-0530
Yes
Carl Mendel, MD/Chief Medical Officer, Synvista
Synvista Therapeutics, Inc
Not Provided
Principal Investigator: Bertram Pitt, MD University of Michigan
Synvista Therapeutics, Inc
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP