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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00379847
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : May 2, 2014
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Baseline-adjusted change in AUC for serum sodium [ Time Frame: 96 Hours ]

Secondary Outcome Measures :
  1. Comparison of safety between patients in each study arm [ Time Frame: 96 Hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379847


Locations
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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
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Study Director: Art Wheeler, MD Cumberland Pharmaceuticals, Inc.
More Information
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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
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014
Keywords provided by Cumberland Pharmaceuticals:
hyponatremia
hypervolemic
euvolemic
treatment outcomes
YM087
Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases
Conivaptan
 Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs