NCT00302250

Brief Summary

The primary objective of the double-blind segment is to compare effects of alagebrium vs placebo on change from baseline in endothelial function, as assessed by flow-mediated vasodilation (FMD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 22, 2006

Status Verified

March 1, 2006

First QC Date

March 13, 2006

Last Update Submit

March 21, 2006

Conditions

Cardiovascular Disease

Keywords

CardiovascularFlow-mediated vasodilation (FMD)Pulse perfusion-mediated vasodilation (PPMV)Endothelial functionHeart failure

Interventions

ALT-711 (alagebrium chloride)DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 50 years of age or greater.
  • Diagnosed with systolic hypertension (systolic blood pressure \>140 mm Hg and (less than or equal to) 200 mm Hg, and a diastolic blood pressure (less than or equal to) 95 mm Hg) and elevated pulse pressure (systolic blood pressure \[SBP\] minus diastolic blood pressure \[DBP\] greater than 60 mm Hg).
  • Normal left ventricular function (ejection fraction \> 55%) at baseline (Visit 3).
  • Brachial artery must be able to be visualized for FMD and PPMV determinations.
  • Able to perform bicycle exercise.
  • Able to read, understand and sign the informed consent after the nature of the study has been explained.
  • If sexually active, the subject agrees to use reliable contraception while participating in this study. If a woman, is surgically sterilized or post-menopausal, or has a negative serum pregnancy test.

You may not qualify if:

  • Aortic stenosis, prior known coronary artery disease (including myocardial infarction), cerebrovascular accident, or peripheral vascular disease.
  • Uncontrolled hypertension (SBP \> 200/DBP \> 95 mm Hg).
  • Atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
  • Any additional condition(s) which, in the opinion of the investigator, would prohibit the subject from completing the study, or not be in the best interest of the subject.
  • Treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
  • Treatment with any investigational drug within 1 month prior to study drug administration.
  • Previous exposure to alagebrium.
  • AST (SGOT) or ALT (SGPT) \> 2x normal limit.
  • Serum creatinine \> 2.0 mg/dL.
  • Cigar/cigarette smoking.
  • Necessity to use smokeless tobacco or nicotine-containing products, or to consume caffeine, alcohol, or antioxidants starting at midnight prior to study clinic visits. NOTE: Water is allowed ad libitim.
  • Positive drug screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

  • Little WC, Zile MR, Kitzman DW, Hundley WG, O'Brien TX, Degroof RC. The effect of alagebrium chloride (ALT-711), a novel glucose cross-link breaker, in the treatment of elderly patients with diastolic heart failure. J Card Fail. 2005 Apr;11(3):191-5. doi: 10.1016/j.cardfail.2004.09.010.

    PMID: 15812746BACKGROUND

  • Kass DA, Shapiro EP, Kawaguchi M, Capriotti AR, Scuteri A, deGroof RC, Lakatta EG. Improved arterial compliance by a novel advanced glycation end-product crosslink breaker. Circulation. 2001 Sep 25;104(13):1464-70. doi: 10.1161/hc3801.097806.

    PMID: 11571237BACKGROUND

  • Liu ZR, Ting CT, Zhu SX, Yin FC. Aortic compliance in human hypertension. Hypertension. 1989 Aug;14(2):129-36. doi: 10.1161/01.hyp.14.2.129.

    PMID: 2759675BACKGROUND

  • Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.

    PMID: 11788217BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Failure

Interventions

alagebrium

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Susan Zieman, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

February 1, 2006

Study Completion

December 1, 2006

Last Updated

March 22, 2006

Record last verified: 2006-03

Locations

US(1)