The STRETCH Study: Distensibility on Endothelial-Dependent Vasoreactivity in Subjects With Systolic Hypertension

Completed · Phase 2

Conditions studied: Cardiovascular Disease

In brief

The primary objective of the double-blind segment is to compare effects of alagebrium vs placebo on change from baseline in endothelial function, as assessed by flow-mediated vasodilation (FMD).

Key facts

Study ID

NCT00302250

Run by

Synvista Therapeutics, Inc

People needed

70

Starts

2006-02-01

Expected to finish

2006-12-01

Last updated by the study team

2006-03-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 50 years of age or greater.
• Diagnosed with systolic hypertension (systolic blood pressure >140 mm Hg and (less than or equal to) 200 mm Hg, and a diastolic blood pressure (less than or equal to) 95 mm Hg) and elevated pulse pressure (systolic blood pressure [SBP] minus diastolic blood pressure [DBP] greater than 60 mm Hg).
• Normal left ventricular function (ejection fraction > 55%) at baseline (Visit 3).
• Brachial artery must be able to be visualized for FMD and PPMV determinations.
• Able to perform bicycle exercise.
• Able to read, understand and sign the informed consent after the nature of the study has been explained.
• If sexually active, the subject agrees to use reliable contraception while participating in this study. If a woman, is surgically sterilized or post-menopausal, or has a negative serum pregnancy test.

You may not qualify if…

• Aortic stenosis, prior known coronary artery disease (including myocardial infarction), cerebrovascular accident, or peripheral vascular disease.
• Uncontrolled hypertension (SBP > 200/DBP > 95 mm Hg).
• Atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
• Any additional condition(s) which, in the opinion of the investigator, would prohibit the subject from completing the study, or not be in the best interest of the subject.
• Treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
• Treatment with any investigational drug within 1 month prior to study drug administration.
• Previous exposure to alagebrium.
• AST (SGOT) or ALT (SGPT) > 2x normal limit.
• Serum creatinine > 2.0 mg/dL.
• Cigar/cigarette smoking.
• Necessity to use smokeless tobacco or nicotine-containing products, or to consume caffeine, alcohol, or antioxidants starting at midnight prior to study clinic visits. NOTE: Water is allowed ad libitim.
• Positive drug screen.

Where it is running

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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