Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

This study has been completed.

Sponsors and Collaborators:	Astellas Pharma Inc Parke-Davis
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00492037

Purpose

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Condition	Intervention	Phase
Hyponatremia	Drug: YM087 oral	Phase III

Drug Information available for: Conivaptan YM 087

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change in serum sodium from Baseline Safety of each dosing regimen [ Time Frame: Beginning through end of treatment ]

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492037

Locations

Sponsors and Collaborators

Astellas Pharma Inc

Parke-Davis

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Study ID Numbers:	087-CL-043, 1025-023
Study First Received:	June 25, 2007
Last Updated:	June 25, 2007
ClinicalTrials.gov Identifier:	NCT00492037
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

hyponatremia
hypervolemic
euvolemic
conivaptan

Study placed in the following topic categories:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009