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

Sponsor

Cumberland Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00379847

Collaborator

(none)

251

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyponatremia	Drug: conivaptan	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

251 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Lower dose	Drug: conivaptan IV Other Names: Vaprisol YM087
Experimental: 2 Higher dose	Drug: conivaptan IV Other Names: Vaprisol YM087

Arm

Intervention/Treatment

Experimental: 1

Lower dose

Drug: conivaptan

Other Names:

Vaprisol

YM087

Experimental: 2

Higher dose

Drug: conivaptan

Other Names:

Vaprisol

YM087

Outcome Measures

Primary Outcome Measures

Baseline-adjusted change in AUC for serum sodium [96 Hours]

Secondary Outcome Measures

Comparison of safety between patients in each study arm [96 Hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1		Tuscon	Arizona	United States	85723
2		Denver	Colorado	United States	80262
3		Washington	District of Columbia	United States	20007
4		Augusta	Georgia	United States	30901
5		Petoskey	Michigan	United States	49700
6		Cincinnati	Ohio	United States	45219
7		Columbia	South Carolina	United States	29209
8		Afula		Israel
9		Ashkelon		Israel
10		Hadera		Israel
11	2 Sites	Haifa		Israel
12		Holon		Israel
13	2 Sites	Jerusalem		Israel
14		Nahariya		Israel
15		Rechovot		Israel
16	2 Sites	Safed		Israel
17		Tel-Aviv		Israel
18		Zerifin		Israel
19		Amanzimototi		South Africa
20		Bellville		South Africa
21		Bloemfontein		South Africa
22	2 Sites	Durban		South Africa
23	4 Sites	Johannesburg		South Africa
24		Krugersdorp		South Africa
25		Lyttelton		South Africa
26		Pretoria		South Africa
27		Somerset West		South Africa
28		Soweto		South Africa