Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Phase 2

Terminated

• Conditions: Hypertension

• Registration Number: NCT00089713
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-08-10
• Study First Submitted QC: 2004-08-11
• Study First Posted: 2004-08-12
• Status Verified: 2005-06
• Last Update Submitted: 2010-02-05
• Last Update Posted: 2010-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 392

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Alteon Inc.; 🇺🇸 Parsippany, New Jersey, United States