Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
A Phase IIIb, Randomized, Double-Blind, Parallel Group, Multi-Center, Study to Assess the Efficacy and Safety of Multiple 30 Minute Infusions of YM087 (Conivaptan) in Subjects With Euvolemic or Hypervolemic Hyponatremia
1 other identifier
interventional
50
2 countries
26
Brief Summary
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2007
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
April 21, 2010
CompletedMay 15, 2014
April 1, 2014
1.3 years
May 22, 2007
March 31, 2010
April 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.
Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1. Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment. Change is calculated as Hour 48 - Baseline.
Baseline and 48 hours
Secondary Outcomes (7)
Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment
Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48
Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium
48 Hours
Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours
48 Hours
Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours
48 Hours
Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours
48 Hours
- +2 more secondary outcomes
Study Arms (3)
Regimen 1 Conivaptan QD
EXPERIMENTAL20 mg conivaptan once a day
Regimen 2 Conivaptan BID
EXPERIMENTAL20 mg conivaptan two times a day
Regimen 3 Placebo
PLACEBO COMPARATORInterventions
premix bag
Eligibility Criteria
You may qualify if:
- Euvolemic or hypervolemic (edematous) based on clinical presentation
- Serum sodium between 115 and 130mEq/L at baseline
You may not qualify if:
- Clinical presentation of volume depletion or dehydration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Tucson, Arizona, 85723, United States
Unknown Facility
Los Angeles, California, 90073, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Port Charlotte, Florida, 33952, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Hazard, Kentucky, 41701, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
The Bronx, New York, 10461, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Fairfield, Ohio, 45014, United States
Unknown Facility
Toledo, Ohio, 43606, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Orangeburg, South Carolina, 29118, United States
Unknown Facility
Coimbatore, 641014, India
Unknown Facility
Indore, 452014, India
Unknown Facility
Jaipur, 302013, India
Unknown Facility
Karnāl, 132001, India
Unknown Facility
Visakhapatnam, 530002, India
Related Publications (1)
Koren MJ, Hamad A, Klasen S, Abeyratne A, McNutt BE, Kalra S. Efficacy and safety of 30-minute infusions of conivaptan in euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 May 1;68(9):818-27. doi: 10.2146/ajhp100260.
PMID: 21515866BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.
Results Point of Contact
- Title
- Senior Medical Director, Medical Affairs
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY DIRECTOR
Art Wheeler, MD
Cumberland Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2007
First Posted
May 24, 2007
Study Start
April 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
May 15, 2014
Results First Posted
April 21, 2010
Record last verified: 2014-04