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

Sponsored by:	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

Drug Information available for: YM 087 Conivaptan

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

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

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

Study placed in the following topic categories:

Metabolic Diseases
Hyponatremia
Edema
Water-Electrolyte Imbalance
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on May 07, 2009