|
The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) Clinical research trials and The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity). The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)  The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)
The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)
For Condition: Hypertension
Status: No longer recruiting
Sponsor(s): Alteon Inc. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 450
Location and Contact Information:
Overall Study Official:
MilanKovacevic, Study Director, Alteon Inc.
Additional Information:
Study ID Numbers: ALT-711-0107;
Study Start Date: October 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045981
Other Hypertension Studies:
1. The Role of Cyclooxygenase Activity in the Endothelial Function of Hypertensive and Hypercholesterolemic Patients
2. Dietary Intervention Study for Hypertension (DISH)
3. Multi-Ethnic Study of Atherosclerosis (MESA)
4. Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow
5. Hypertension in Black Americans: A Life Course Approach
Related Studies:
Other Hypertension Clinical Trials
Other Clinical Trials
Other Clinical Trials
The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity)
|
|
|
|
|
|
|
|
