An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyponatremia | Drug: conivaptan | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Lower dose
|
Drug: conivaptan
IV
Other Names:
|
Experimental: 2
Higher dose
|
Drug: conivaptan
IV
Other Names:
|
- Baseline-adjusted change in AUC for serum sodium [ Time Frame: 96 Hours ]
- Comparison of safety between patients in each study arm [ Time Frame: 96 Hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. |
Responsible Party: | Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc. |
ClinicalTrials.gov Identifier: | NCT00379847 |
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 |
hyponatremia hypervolemic euvolemic treatment outcomes YM087 |
Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases Conivaptan |
Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |