Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

This study has been terminated.
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00089713
First received: August 10, 2004
Last updated: February 5, 2010
Last verified: June 2005
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Synvista Therapeutics, Inc:

Estimated Enrollment: 392
Study Start Date: March 2004
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 10, 2004
Last Updated: February 5, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014