Clinical trial NCT00089713: Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)
Official title: Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Keywords: antihypertensive agents/therapeutic use
hypertension/drug therapy
blood pressure
Lead sponsor: Synvista Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2004-08-12
Enrollment: 392
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Alteon Inc.
state: New Jersey
Study officials:
affiliation: Synvista Therapeutics, Inc
name: Milan Kovacevic, MD, PhD
role: STUDY_DIRECTOR
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