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Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alagebrium chloride (ALT-711)
Sponsored by
Synvista Therapeutics, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring antihypertensive agents/therapeutic use, hypertension/drug therapy, blood pressure

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Alteon Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2004
Last Updated
February 5, 2010
Sponsor
Synvista Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00089713
Brief Title
Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)
Official Title
Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Terminated
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Synvista Therapeutics, Inc

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
antihypertensive agents/therapeutic use, hypertension/drug therapy, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
392 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
alagebrium chloride (ALT-711)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milan Kovacevic, MD, PhD
Organizational Affiliation
Synvista Therapeutics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Alteon Inc.
City
Parsippany
State/Province
New Jersey
ZIP/Postal Code
07054
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11571237
Citation
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Results Reference
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PubMed Identifier
10706607
Citation
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. Erratum In: Proc Natl Acad Sci U S A 2000 May 9;97(10):5679.
Results Reference
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PubMed Identifier
9539789
Citation
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.
Results Reference
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PubMed Identifier
11158613
Citation
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.
Results Reference
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PubMed Identifier
11519509
Citation
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.
Results Reference
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PubMed Identifier
11519501
Citation
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. Erratum In: N Engl J Med 2002 Feb 14;346(7):544.
Results Reference
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PubMed Identifier
10864525
Citation
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Results Reference
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PubMed Identifier
3487117
Citation
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.
Results Reference
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PubMed Identifier
1728930
Citation
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.
Results Reference
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PubMed Identifier
12946933
Citation
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.
Results Reference
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Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

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