Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Phase 2TerminatedNCT00089713

Synvista Therapeutics, Inc392 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

392

Conditions

Hypertension

Interventions

alagebrium chloride (ALT-711)DRUG

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alteon Inc.

Parsippany, New Jersey, United States

Data from ClinicalTrials.gov

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