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Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00089713
First Posted: August 12, 2004
Last Update Posted: February 8, 2010
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.
Information provided by:
Synvista Therapeutics, Inc
  Purpose
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
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00089713


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

Publications:

ClinicalTrials.gov Identifier: NCT00089713     History of Changes
Other Study ID Numbers: ALT-711-0320
First Submitted: August 10, 2004
First Posted: August 12, 2004
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases