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The SILVER Study: Systolic Hypertension Interaction With Left Ventricular Remodeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00045994
Recruitment Status : Completed
First Posted : September 19, 2002
Last Update Posted : July 29, 2009
Information provided by:
Synvista Therapeutics, Inc

Brief 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 study in patients with left ventricular hypertrophy. Eligible patients will be randomized to double-blind treatment once daily for 6 months with oral ALT-711 (210 mg) or placebo.

Condition or disease Intervention/treatment Phase
Hypertension Hypertrophy, Left Ventricular Drug: ALT-711 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Systolic and Pulse Pressure Hemodynamic Improvement By Restoring Elasticity: The SILVER Study
Study Start Date : August 2001
Actual Primary Completion Date : January 2002
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 with 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00045994

Sponsors and Collaborators
Synvista Therapeutics, Inc
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Study Director: Milan Kovacevic, MD, PhD Synvista Therapeutics, Inc

Layout table for additonal information Identifier: NCT00045994    
Other Study ID Numbers: ALT-711-0107-Silver
First Posted: September 19, 2002    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: August 2007
Keywords provided by Synvista Therapeutics, Inc:
antihypertensive agents/therapeutic use
hypertension/*drug therapy
blood pressure
Additional relevant MeSH terms:
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Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Diseases