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Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients

This study has been withdrawn prior to enrollment.
(Unable to complete a contract with the Sponsor.)
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00684164
First received: May 22, 2008
Last updated: February 10, 2009
Last verified: February 2009

May 22, 2008
February 10, 2009
May 2008
November 2009   (final data collection date for primary outcome measure)
Mean change in serum sodium over the duration of treatment between the two treatment arms. [ Time Frame: From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00684164 on ClinicalTrials.gov Archive Site
The percentage of patients requiring study drug discontinuation for any reason other than reaching the sodium endpoint, including those with too rapid a rise in serum sodium (>12 mEq rise over 24 hours) or an infusion site reaction [ Time Frame: From the initiation of treatment to the end of treatment, up to 4 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients
Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients

Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body.

FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hyponatremia
  • Drug: Conivaptan
    20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days
    Other Name: VAPRISOL
  • Other: D5
    Volume loading dose of D5 followed by an infusion of D5 over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached.
  • Experimental: 1
    Subjects in the treatment group will receive standard medical treatment plus Conivaptan administered as a 20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached.
    Intervention: Drug: Conivaptan
  • Placebo Comparator: 2
    Subjects in the placebo control group will receive an equivalent volume loading dose of D5 followed by an infusion of D5 in the same manner as the experimental group.
    Intervention: Other: D5
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
June 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute neurological injury
  • Euvolemia or hypervolemia (defined clinically by examination, recent I+Os, BUN/creatinine ratio and CVP [if available])
  • Serum sodium less than or equal to 132 mEq/L (confirmed as hypoosmolar hyponatremia by a concurrent source: osmolality measurements [<280 mosoms/L] or by a preceding serum Na+ value <135 mEq/L0

Exclusion Criteria:

  • Patients who have uncontrolled hypertension; significant orthostatic hypotension or supine systolic blood pressure less than 85 mm Hg;
  • Uncontrolled arrhythmias;
  • Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency;
  • Estimated creatinine clearance less than 20 ml/min;
  • Urinary outflow obstruction unless catheterized;
  • Alanine aminotransferase (ALT) >3x ULN
  • Aspartate aminotransferase (AST) >3x ULN
  • Serum albumin of 1.5 g/dl or less;
  • Prothrombin time greater than 22 sec or an international normalized ratio (INR) greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy; a white blood cell count less than 3000/µl;
  • HIV infection;
  • Active hepatitis.
  • Pregnant or nursing
  • Participation in a clinical trial of an investigational drug or device within 30 days of screening
  • Unable to obtain written consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684164
AAAC6833
Yes
Stephan A. Mayer, MD, Columbia University Medical Center
Columbia University
Astellas Pharma Inc
Principal Investigator: Stephan A. Mayer, MD Columbia University
Columbia University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP