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

This study has been completed.

First Received: September 21, 2006 Last Updated: July 16, 2008 History of Changes

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00379847

Purpose

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.

Condition	Intervention	Phase
Hyponatremia	Drug: conivaptan	Phase III

Drug Information available for: YM 087 Conivaptan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 4-Day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	251
Study Start Date:	February 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lower dose	Drug: conivaptan IV
2: Experimental Higher dose	Drug: conivaptan IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379847

Locations

United States, Arizona

Tuscon, Arizona, United States, 85723
United States, Colorado

Denver, Colorado, United States, 80262
United States, District of Columbia

Washington, District of Columbia, United States, 20007
United States, Georgia

Augusta, Georgia, United States, 30901
United States, Michigan

Petoskey, Michigan, United States, 49700
United States, Ohio

Cincinnati, Ohio, United States, 45219
United States, South Carolina

Columbia, South Carolina, United States, 29209
Israel

Hadera, Israel

Rechovot, Israel

Ashkelon, Israel
2 Sites
Safed, Israel
2 Sites
Haifa, Israel
2 Sites
Jerusalem, Israel

Tel-Aviv, Israel

Nahariya, Israel

Zerifin, Israel

Holon, Israel

Afula, Israel
South Africa

Amanzimototi, South Africa
2 Sites
Durban, South Africa

Bellville, South Africa

Krugersdorp, South Africa
4 Sites
Johannesburg, South Africa

Lyttelton, South Africa

Pretoria, South Africa

Bloemfontein, South Africa

Soweto, South Africa

Somerset West, South Africa

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	087-CL-080
Study First Received:	September 21, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00379847 History of Changes
Health Authority:	United States: Food and Drug Administration; Israel: Israeli Health Ministry Pharmaceutical Administration; South Africa: Medicines Control Council

Keywords provided by Astellas Pharma Inc:

hyponatremia
hypervolemic
euvolemic
treatment outcomes
YM087

Study placed in the following topic categories:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on May 07, 2009