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

This study has been completed.

First Received: May 22, 2007 Last Updated: September 11, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00478192

Purpose

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

Condition	Intervention	Phase
Hyponatremia	Drug: Conivaptan Drug: Placebo	Phase III

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

Resource links provided by NLM:

Drug Information available for: YM 087 Conivaptan

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change in serum sodium from Baseline. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Safety of each dosing regimen [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	April 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dosing regimen 1	Drug: Conivaptan premix bag
2: Experimental dosing regimen 2	Drug: Conivaptan premix bag
3: Placebo Comparator	Drug: Placebo premix bag

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478192

Locations

United States, Alabama

Huntsville, Alabama, United States, 35801
United States, Arizona

Tucson, Arizona, United States, 85723
United States, California

Los Angeles, California, United States, 90073
United States, Colorado

Denver, Colorado, United States, 80218
United States, Florida

Jacksonville, Florida, United States, 32216

Port Charlotte, Florida, United States, 33952
United States, Illinois

Chicago, Illinois, United States, 60612
United States, Indiana

Indianapolis, Indiana, United States, 46260
United States, Kentucky

Hazard, Kentucky, United States, 41701
United States, Michigan

Detroit, Michigan, United States, 48201
United States, Nebraska

Omaha, Nebraska, United States, 68198
United States, New York

Bronx, New York, United States, 10461
United States, Ohio

Toledo, Ohio, United States, 43606

Cincinnati, Ohio, United States, 45267

Fairfield, Ohio, United States, 45014
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19140

Philadelphia, Pennsylvania, United States, 19104

Philadelphia, Pennsylvania, United States, 19107

Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina

Charleston, South Carolina, United States, 29425

Orangeburg, South Carolina, United States, 29118
India

Jaipur, India, 302013

Coimbatore, India, 641014

Indore, India, 452014

Karnal, India, 132001

Visakhapatnam, India, 530002

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	087-CL-088
Study First Received:	May 22, 2007
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00478192 History of Changes
Health Authority:	United States: Food and Drug Administration; India: Drugs Controller General of India

Keywords provided by Astellas Pharma Inc:

hyponatremia
hypervolemic
euvolemic
edematous
conivaptan

Additional relevant MeSH terms:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 27, 2009