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

This study has been completed.
Sponsor:
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00379847
First received: September 21, 2006
Last updated: April 30, 2014
Last verified: April 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

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
Experimental: 1
Lower dose
Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087
Experimental: 2
Higher dose
Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Afula, Israel
Ashkelon, Israel
Hadera, Israel
2 Sites
Haifa, Israel
Holon, Israel
2 Sites
Jerusalem, Israel
Nahariya, Israel
Rechovot, Israel
2 Sites
Safed, Israel
Tel-Aviv, Israel
Zerifin, Israel
South Africa
Amanzimototi, South Africa
Bellville, South Africa
Bloemfontein, South Africa
2 Sites
Durban, South Africa
4 Sites
Johannesburg, South Africa
Krugersdorp, South Africa
Lyttelton, South Africa
Pretoria, South Africa
Somerset West, South Africa
Soweto, South Africa
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00379847     History of Changes
Other Study ID Numbers: 087-CL-080
Study First Received: September 21, 2006
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration
Israel: Israeli Health Ministry Pharmaceutical Administration
South Africa: Medicines Control Council

Keywords provided by Cumberland Pharmaceuticals:
hyponatremia
hypervolemic
euvolemic
treatment outcomes
YM087

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on July 09, 2014