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

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

ChemIDplus related topics:

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

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

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	087-CL-080
First Received:	September 21, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00379847
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

ClinicalTrials.gov processed this record on October 15, 2008

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