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

Tracking Information

First Received Date ^ICMJE

May 22, 2007

Last Updated Date

September 11, 2008

Start Date ^ICMJE

April 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change in serum sodium from Baseline. Safety of each dosing regimen

Change History

Complete list of historical versions of study NCT00478192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hyponatremia

Intervention ^ICMJE

Drug: Conivaptan
Drug: Placebo

Study Arms / Comparison Groups

Experimental: dosing regimen 1
Experimental: dosing regimen 2

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, India

Administrative Information

NCT ID ^ICMJE

NCT00478192

Responsible Party

Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc

Study ID Numbers ^ICMJE

087-CL-088

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP