NCT00089713

Brief Summary

This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2004

Completed
Last Updated

February 8, 2010

Status Verified

June 1, 2005

First QC Date

August 10, 2004

Last Update Submit

February 5, 2010

Conditions

Hypertension

Keywords

antihypertensive agents/therapeutic usehypertension/drug therapyblood pressure

Interventions

alagebrium chloride (ALT-711)DRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women at least 45 years of age with uncontrolled systolic hypertension measured by office cuff and by an ambulatory blood pressure monitoring device
  • Willingness to be taken off any current antihypertensive treatment to be placed on hydrochlorothiazide in combination with study medication.

You may not qualify if:

  • Any significant history, systemic illnesses, or medical condition(s) that could lead to difficulty complying with the protocol or that could confound interpretation of the data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alteon Inc.

Parsippany, New Jersey, 07054, United States

Location

Related Publications (10)

  • 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

  • Asif M, Egan J, Vasan S, Jyothirmayi GN, Masurekar MR, Lopez S, Williams C, Torres RL, Wagle D, Ulrich P, Cerami A, Brines M, Regan TJ. An advanced glycation endproduct cross-link breaker can reverse age-related increases in myocardial stiffness. Proc Natl Acad Sci U S A. 2000 Mar 14;97(6):2809-13. doi: 10.1073/pnas.040558497.

    PMID: 10706607BACKGROUND

  • Wolffenbuttel BH, Boulanger CM, Crijns FR, Huijberts MS, Poitevin P, Swennen GN, Vasan S, Egan JJ, Ulrich P, Cerami A, Levy BI. Breakers of advanced glycation end products restore large artery properties in experimental diabetes. Proc Natl Acad Sci U S A. 1998 Apr 14;95(8):4630-4. doi: 10.1073/pnas.95.8.4630.

    PMID: 9539789BACKGROUND

  • Vaitkevicius PV, Lane M, Spurgeon H, Ingram DK, Roth GS, Egan JJ, Vasan S, Wagle DR, Ulrich P, Brines M, Wuerth JP, Cerami A, Lakatta EG. A cross-link breaker has sustained effects on arterial and ventricular properties in older rhesus monkeys. Proc Natl Acad Sci U S A. 2001 Jan 30;98(3):1171-5. doi: 10.1073/pnas.98.3.1171.

    PMID: 11158613BACKGROUND

  • Chobanian AV. Control of hypertension--an important national priority. N Engl J Med. 2001 Aug 16;345(7):534-5. doi: 10.1056/NEJM200108163450709. No abstract available.

    PMID: 11519509BACKGROUND

  • Hyman DJ, Pavlik VN. Characteristics of patients with uncontrolled hypertension in the United States. N Engl J Med. 2001 Aug 16;345(7):479-86. doi: 10.1056/NEJMoa010273.

    PMID: 11519501BACKGROUND

  • Wilkinson IB, Webb Christison DJ, Cockcroft JR. Isolated systolic hypertension: a radical rethink. It's a risk factor that needs treatment, especially in the over 50s. BMJ. 2000 Jun 24;320(7251):1685. doi: 10.1136/bmj.320.7251.1685. No abstract available.

    PMID: 10864525BACKGROUND

  • Brownlee M, Vlassara H, Kooney A, Ulrich P, Cerami A. Aminoguanidine prevents diabetes-induced arterial wall protein cross-linking. Science. 1986 Jun 27;232(4758):1629-32. doi: 10.1126/science.3487117.

    PMID: 3487117BACKGROUND

  • Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64.

    PMID: 1728930BACKGROUND

  • Liu J, Masurekar MR, Vatner DE, Jyothirmayi GN, Regan TJ, Vatner SF, Meggs LG, Malhotra A. Glycation end-product cross-link breaker reduces collagen and improves cardiac function in aging diabetic heart. Am J Physiol Heart Circ Physiol. 2003 Dec;285(6):H2587-91. doi: 10.1152/ajpheart.00516.2003. Epub 2003 Aug 28.

    PMID: 12946933BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

alagebrium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Milan Kovacevic, MD, PhD

    Synvista Therapeutics, Inc

    STUDY DIRECTOR

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

August 10, 2004

First Posted

August 12, 2004

Study Start

March 1, 2004

Last Updated

February 8, 2010

Record last verified: 2005-06

Locations

US(1)