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ALT-711

Phase 2

Cardiovascular Disease | Small Molecules | Cardiovascular |SYNVISTA THERAPEUTICS, INC|Trials Updated: Mar 26, 2010

ALT-711 development status

Highest phase Phase 2
Registered trials 7 across 1 sponsor since Aug 2002

ALT-711 target and mechanism

ModalitySmall Molecules

Also known as ALT-711 (alagebrium chloride), Alagebrium

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment665

FDA Designations

No designations recorded

ALT-711 clinical trials

ALT-711 · 5 trials · 6 indications

Phase 2 5
NCT00516646The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart FailureHeart Failure
COMPLETED100 Analytics
NCT00302250The STRETCH Study: Distensibility on Endothelial-Dependent Vasoreactivity in Subjects With Systolic HypertensionCardiovascular Disease
COMPLETED70 Analytics
NCT00277875STRETCH Study: Effect of Distensibility on Endothelial-Dependent Vasoreactivity in Patients With ISHCardiovascular Disease
COMPLETED25 Analytics
NCT00043836The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart FailureHeart Failure, Congestive
COMPLETED20 Analytics
NCT00045981The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)Hypertension
COMPLETED450 Analytics
PHASE2COMPLETED
The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
Heart Failure
NCT00516646100
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PHASE2COMPLETED
The STRETCH Study: Distensibility on Endothelial-Dependent Vasoreactivity in Subjects With Systolic Hypertension
Cardiovascular Disease
NCT0030225070
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PHASE2COMPLETED
STRETCH Study: Effect of Distensibility on Endothelial-Dependent Vasoreactivity in Patients With ISH
Cardiovascular Disease
NCT0027787525
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PHASE2COMPLETED
The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
Heart Failure, Congestive
NCT0004383620
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PHASE2COMPLETED
The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)
Hypertension
NCT00045981450
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Study Endpoints

Primary Endpoints

The primary end-point of the study will be aerobic capacity (VO2max) measured at exercise testing
At baseline and after 9 months of study drug
Endothelial function
Local distensibility
Arterial stiffening
Augmentation index (AI)
Markers of endothelial function, vascular inflammation and collagen synthesis.

Secondary Endpoints

Changes in systolic function, diastolic function, advanced glycation end-products (AGE) measurements, changes in Minnesota Living with Heart Failure score, NYHA heart failure score, patient's and physician's global assessment, and NT-pro-BNP
At baseline and after 9 months of study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORALT-711 200 mg bid
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALT-711DRUG200 mg bid
PlaceboDRUGbid
ALT-711 (alagebrium chloride)DRUG -
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Eligibility Criteria

Age Range19 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * NYHA II-IV heart failure * Echocardiographic ejection fraction ≤ 40% * Duration of heart failure \> 3 months * Stable heart failure medical therapy for \> 1 months Exclusion Criteria: * History of myocardial infarction in previous 6 months * History of stroke in previous 6 m...

Countries:NetherlandsUnited States
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Competitive Landscape -General Cardiovascular Diseases 65 trials (matched to "Cardiovascular Disease")

Top 4 of 18 competitors

CompanyTickerTrialsLead PhaseDrugs
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Roivant Sciences Ltd.ROIV3PHASE3Mosliciguat
Eli Lilly and CompanyLLY2PHASE3Eloralintide, Lepodisiran
Illumina, Inc.ILMN1PHASE218F-mFBG for administration
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