Overview

Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Synvista Therapeutics, Inc
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.