Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Synvista Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Hypertension

Treatments

Drug: alagebrium chloride (ALT-711)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00089713

ALT-711-0320

Details and patient eligibility

About

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).

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.