An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
This study has been completed.
Sponsor:
Cumberland Pharmaceuticals
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00379847
First received: September 21, 2006
Last updated: April 30, 2014
Last verified: April 2014
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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 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:
|
|
Experimental: 2
Higher dose
|
Drug: conivaptan
IV
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
| 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 Conivaptan |
Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 27, 2016