A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyponatremia; Euvolemia; Hypervolemia
Intervention: Conivaptan (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
Overall contact:
Astellas Pharma US Medical Information, Phone: 800-888-7704 x5473, Email: clintrials.info@us.astellas.com
Summary
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV
conivaptan in subjects with euvolemic or hypervolemic hyponatremia
Clinical Details
Official title: A Phase 4, Randomized, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens
Secondary outcome: Change from baseline in serum sodium
Baseline-adjusted area under the curve (AUC) in serum sodium
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject has a serum sodium value between 115 and 133 mEq/L
- Subject is euvolemic or hypervolemic
Exclusion Criteria:
- Clinical evidence of volume depletion or dehydration
- Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or
treatment
Locations and Contacts
Astellas Pharma US Medical Information, Phone: 800-888-7704 x5473, Email: clintrials.info@us.astellas.com
Karnal 132001, India; Recruiting
Bangalore 560034, India; Recruiting
Gujarat 382428, India; Active, not recruiting
Bangalore 560099, India; Recruiting
Hyderabad 500482, India; Recruiting
Bhopal 462001, India; Recruiting
Safed 13100, Israel; Recruiting
Holon 58100, Israel; Recruiting
Haifa 31096, Israel; Recruiting
Zerifin 70300, Israel; Recruiting
Haifa 31048, Israel; Active, not recruiting
Hadera 38100, Israel; Withdrawn
Afula 18101, Israel; Recruiting
Rechovot 76100, Israel; Recruiting
Ashkelon 78308, Israel; Recruiting
Jerusalem 91120, Israel; Recruiting
Tel Hashomer 52621, Israel; Recruiting
Tel-Aviv 64239, Israel; Recruiting
Petach Tikva 49100, Israel; Active, not recruiting
Haifa 34362, Israel; Recruiting
Jerusalem 910301, Israel; Active, not recruiting
Washington, District of Columbia 20007, United States; Withdrawn
Chicago, Illinois 60612, United States; Withdrawn
Bronx, New York 10461, United States; Withdrawn
Charleston, South Carolina 29425, United States; Active, not recruiting
Additional Information
Starting date: January 2007
Ending date: November 2008
Last updated: July 9, 2008
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