The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)
This study has been completed.
Information provided by:
Synvista Therapeutics, Inc
First received: September 17, 2002
Last updated: March 25, 2010
Last verified: August 2007
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Systolic and Pulse Pressure Hemodynamic Improvement By Restoring Elasticity: The SAPPHIRE Study
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2003 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045981
Synvista Therapeutics, Inc
||Milan Kovacevic, MD, PhD
||Synvista Therapeutics, Inc
Asif M, Egan J, Vasan S, Jyothirmayi GN, Masurekar MR, Lopez S, Williams C, Torres RL, Wagle D, Ulrich P, Cerami A, Brines M, Regan TJ. An advanced glycation endproduct cross-link breaker can reverse age-related increases in myocardial stiffness. Proc Natl Acad Sci U S A. 2000 Mar 14;97(6):2809-13. Erratum in: Proc Natl Acad Sci U S A 2000 May 9;97(10):5679.
Wolffenbuttel BH, Boulanger CM, Crijns FR, Huijberts MS, Poitevin P, Swennen GN, Vasan S, Egan JJ, Ulrich P, Cerami A, Lévy BI. Breakers of advanced glycation end products restore large artery properties in experimental diabetes. Proc Natl Acad Sci U S A. 1998 Apr 14;95(8):4630-4.
Vaitkevicius PV, Lane M, Spurgeon H, Ingram DK, Roth GS, Egan JJ, Vasan S, Wagle DR, Ulrich P, Brines M, Wuerth JP, Cerami A, Lakatta EG. A cross-link breaker has sustained effects on arterial and ventricular properties in older rhesus monkeys. Proc Natl Acad Sci U S A. 2001 Jan 30;98(3):1171-5.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 17, 2002
||March 25, 2010
||United States: Food and Drug Administration
Keywords provided by Synvista Therapeutics, Inc:
ClinicalTrials.gov processed this record on February 04, 2016
antihypertensive agents/therapeutic use