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Tracking Information | |
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First Received Date † | August 21, 2008 |
Last Updated Date | January 29, 2009 |
Start Date † | August 2008 |
Current Primary Outcome Measures † |
The primary end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase. [ Time Frame: 9 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00739687 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure |
Official Title † | A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure |
Brief 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. |
Detailed Description | |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition † | Chronic Heart Failure |
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Terminated |
Enrollment † | 100 |
Estimated Completion Date | October 2009 |
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00739687 |
Responsible Party | Adriaan A. Voors, MD, PhD, University Medical Center Groningen, Groningen, The Netherlands |
Secondary IDs †† | |
Study Sponsor † | Synvista Therapeutics, Inc |
Collaborators †† | |
Investigators † | |
Information Provided By | Synvista Therapeutics, Inc |
Verification Date | January 2009 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |