Overview

The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and efficacy of ALT-711 in the treatment of isolated systolic hypertension in a formal dose-ranging study in patients without left ventricular hypertrophy. Eligible patients will be randomized to double-blind treatment once daily for 6 months with oral ALT-711 (35, 70, 140, or 210 mg) or placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Synvista Therapeutics, Inc
Criteria
Inclusion Criteria

- Men or women at least 50 years of age.

- Screening diagnosis of isolated systolic hypertension, defined as systolic blood
pressure >150 mm Hg and diastolic blood pressure <90 mm Hg (office blood pressure
measurements) and systolic blood pressure >140 mm Hg (measured by 24-hour ambulatory
blood pressure monitoring-mean daytime values).

- Baseline systolic blood pressure >150 mm Hg and diastolic blood pressure <90 mm Hg
(office blood pressure measurements).

- Patients without left ventricular hypertrophy (LVH) as determined by limited
echocardiography for LVH (i.e., wall thickness < 1.2 cm).

- Patient can complete an informed consent.

Exclusion Criteria

- Patient <50 years of age.

- Patients on antihypertensive therapy with changes in dose in the last 1 month prior to
the entry into the study.

- Hb A1c > 9%.

- Serum creatinine > 1.7mg/dL.

- History of ketoacidosis or uncontrolled diabetes within the last 2 years.

- History of congestive heart failure.

- History of stroke, or any sequelae of a transient ischemic attack, reversible ischemic
neurologic defect, or stroke, within the last 12 months.

- History of acute myocardial infarction within 6 months prior to entry into the study.

- Any significant ECG abnormalities, including second degree AV-block or complete
AV-block. Any known significant arrhythmia including atrial flutter, ventricular
tachycardia, WPW-syndrome. Any hemodynamically significant valvular heart disease.

- Any significant systemic illnesses or medical condition that could lead to difficulty
complying with the protocol.

- Screening or Baseline liver function tests SGOT and/or SGPT > 2.0 times the upper
limits of central laboratory normal range.

- Use of systemic and/or inhaled corticosteroids (excluding topical corticosteroids).

- Any additional condition(s), which in the investigator's opinion would prohibit the
patient from completing the study, or not be in the best interest of the patient.

- Use of any investigational drugs within 30 days prior to screening.

- Previous exposure to ALT-711.

- Known seropositivity for HIV or hepatitis C, or presence of hepatitis B surface
antigen.

- Pregnancy or active breast-feeding. Female patients of childbearing potential (not
postmenopausal for at least 5 years or surgically sterilized) must agree not to become
pregnant during the duration of the study. Specifically, they must agree to use an
appropriate contraceptive regimen. Acceptable regimens include abstinence, systemic
hormones, intrauterine devices and barrier methods, such as cervical caps, male or
female condoms, or diaphragms with concomitant intravaginal spermicide. A barrier
method must have been used without failure for at least 1 year immediately preceding
entry into the study.

- Positive drug screen.

- Necessity to use tobacco or nicotine-containing products, or to consume caffeine-
containing beverages and/or food, and/or alcohol after midnight prior to clinic visit
days, until after any evaluations.