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Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00089713
Recruitment Status : Terminated
First Posted : August 12, 2004
Last Update Posted : February 8, 2010
Information provided by:
Synvista Therapeutics, Inc

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).

Condition or disease Intervention/treatment Phase
Hypertension Drug: alagebrium chloride (ALT-711) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients
Study Start Date : March 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00089713

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United States, New Jersey
Alteon Inc.
Parsippany, New Jersey, United States, 07054
Sponsors and Collaborators
Synvista Therapeutics, Inc
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Study Director: Milan Kovacevic, MD, PhD Synvista Therapeutics, Inc


Layout table for additonal information Identifier: NCT00089713     History of Changes
Other Study ID Numbers: ALT-711-0320
First Posted: August 12, 2004    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: June 2005

Keywords provided by Synvista Therapeutics, Inc:
antihypertensive agents/therapeutic use
hypertension/drug therapy
blood pressure

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases