Status:
COMPLETED
The STRETCH Study: Distensibility on Endothelial-Dependent Vasoreactivity in Subjects With Systolic Hypertension
Lead Sponsor:
Synvista Therapeutics, Inc
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart and Lung Institute
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
The secondary objectives of the double-blind segment are to: * Compare the effects of alagebrium vs placebo on the change from baseline in endothelial-mediated vasoreactivity immediately after exerci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00302250
Start Date
February 1 2006
End Date
December 1 2006
Last Update
March 22 2006
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287