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

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 09, 2009