An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 21, 2006

Last Updated Date

July 16, 2008

Start Date ^ICMJE

February 2004

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Baseline-adjusted change in AUC for serum sodium [ Time Frame: 96 Hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy outcome will be baseline-adjusted change in AUC for serum sodium over the 96-hour infusion. The primary safety outcome will be to compare the safety in patients treated with 20mg/day to the safety in patients treated with 40mg/day

Change History

Complete list of historical versions of study NCT00379847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of safety between patients in each study arm [ Time Frame: 96 Hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Official Title ^ICMJE

A 4-Day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia

Brief Summary

This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hyponatremia

Intervention ^ICMJE

Drug: conivaptan

Study Arms / Comparison Groups

Experimental: Lower dose
Experimental: Higher dose

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

251

Completion Date

June 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Serum sodium levels less than or equal 130mEq/L
Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria:

Clinical evidence of volume depletion or dehydration
Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

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, Israel, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00379847

Responsible Party

Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.

Study ID Numbers ^ICMJE

087-CL-080

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

June 2008

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