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Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). Clinical research trials and Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).. Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). clinical trial. Participants typically obtain the most effective healthcare available for their Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT). condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

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Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).



Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

For Condition: Chronic Heart Failure
Status: Completed
Sponsor(s): Sanofi-Synthelabo ,
Synopsis: This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: - Men or women with chronic heart failure (NYHA Class IIIB and IV). - Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing. - Age 21 to 80 years. - Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time. - Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure. - Patients may be receiving digoxin, a beta-blocker or spironolacton
Total Enrollment: 300

Location and Contact Information:

University of Maryland School of Medicine
Baltimore,  Maryland,  21201
United States
 

MUSC/Division Cardiology
Charleston,  South Carolina,  29425
United States
 

University of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

The Lindner Clinical Trial Center
Cincinnati,  Ohio,  45219
United States
 

University of Iowa Hospital and Clinics
Iowa City,  Iowa,  52242-1081
United States
 

Brian LGH Heart Institute
Lincoln,  Nebraska,  68510
United States
 

Emory University
Atlanta,  Georgia,  30322
United States
 


Additional Information:
Study ID Numbers:
  DFI4510;  SR121463B
Study Start Date: August 2001
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032747

Other Chronic Heart Failure Studies:
1. Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

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Safety study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

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