Study of Efficacy & Safety for 3 Infusion Regimens of IV YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

Condition(s) targeted: Hyponatremia

Intervention: Conivaptan (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

Overall contact:
Astellas Pharma US Medical Information, Phone: 800-888-7704 x5473, Email: clintrials.info@us.astellas.com

The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Official title: A Phase IIIb, Randomized, Double-Blind, Parallel Group, Multi-Center, Study to Assess the Efficacy and Safety of Multiple 30 Minute Infusions of YM087 (Conivaptan) in Subjects With Euvolemic or Hypervolemic Hyponatremia

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change in serum sodium from Baseline.

Safety of each dosing regimen

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Euvolemic or hypervolemic (edematous) based on clinical presentation

- Serum sodium between 115 and 130mEq/L at baseline

Exclusion Criteria:

- Clinical presentation of volume depletion or dehydration

Astellas Pharma US Medical Information, Phone: 800-888-7704 x5473, Email: clintrials.info@us.astellas.com

Jaipur 302013, India; Recruiting

Coimbatore 641014, India; Recruiting

Indore 452014, India; Active, not recruiting

Ghaziabad 201002, India; Not yet recruiting

Karnal 132001, India; Not yet recruiting

Visakhapatnam 530002, India; Active, not recruiting

Huntsville, Alabama 35801, United States; Recruiting

Tucson, Arizona 85723, United States; Active, not recruiting

Los Angeles, California 90073, United States; Active, not recruiting

Denver, Colorado 80218, United States; Recruiting

Jacksonville, Florida 32216, United States; Recruiting

Port Charlotte, Florida 33952, United States; Recruiting

Augusta, Georgia 30901, United States; Withdrawn

Chicago, Illinois 60612, United States; Active, not recruiting

Indianapolis, Indiana 46260, United States; Active, not recruiting

Hazard, Kentucky 41701, United States; Recruiting

Boston, Massachusetts 02135, United States; Withdrawn

Detroit, Michigan 48201, United States; Recruiting

Omaha, Nebraska 68198, United States; Active, not recruiting

Newark, New Jersey 07103, United States; Withdrawn

Bronx, New York 10461, United States; Recruiting

Toledo, Ohio 43606, United States; Active, not recruiting

Cincinnati, Ohio 45267, United States; Recruiting

Fairfield, Ohio 45014, United States; Active, not recruiting

Philadelphia, Pennsylvania 19140, United States; Active, not recruiting

Philadelphia, Pennsylvania 19104, United States; Recruiting

Philadelphia, Pennsylvania 19107, United States; Active, not recruiting

Philadelphia, Pennsylvania 19102, United States; Recruiting

Charleston, South Carolina 29425, United States; Recruiting

Orangeburg, South Carolina 29118, United States; Recruiting

Memphis, Tennessee 38120, United States; Withdrawn

Salt Lake City, Utah 84132, United States; Withdrawn

Richmond, Virginia 23298, United States; Withdrawn

Starting date: April 2007
Ending date: August 2008
Last updated: July 9, 2008