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Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00089713
Enrollment
392
Registered
2004-08-12
Start date
2004-03-31
Completion date
Unknown
Last updated
2010-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

antihypertensive agents/therapeutic use, hypertension/drug therapy, blood pressure

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).

Interventions

DRUGalagebrium chloride (ALT-711)

Sponsors

Synvista Therapeutics, Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026