An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
This study has been completed.
Sponsor:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00379847
First Posted: September 25, 2006
Last Update Posted: May 2, 2014
Information provided by:
Cumberland Pharmaceuticals
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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 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 |
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 ]
Secondary Outcome Measures:
- Comparison of safety between patients in each study arm [ Time Frame: 96 Hours ]
| 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:
|
|
Experimental: 2
Higher dose
|
Drug: conivaptan
IV
Other Names:
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
| 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
| 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 Submitted: | September 21, 2006 |
| First Posted: | September 25, 2006 |
| 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:
|
Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases Conivaptan |
Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |