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Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

This study has been terminated.
Information provided by:
Synvista Therapeutics, Inc Identifier:
First received: August 10, 2004
Last updated: February 5, 2010
Last verified: June 2005
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 Intervention Phase
Hypertension Drug: alagebrium chloride (ALT-711) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients

Further study details as provided by Synvista Therapeutics, Inc:

Estimated Enrollment: 392
Study Start Date: March 2004

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00089713

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

Publications: Identifier: NCT00089713     History of Changes
Other Study ID Numbers: ALT-711-0320
Study First Received: August 10, 2004
Last Updated: February 5, 2010

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on July 19, 2017