NCT00435591

Brief Summary

The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
3 countries

18 active sites

Status
completed

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

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 26, 2010

Completed
Last Updated

May 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

February 14, 2007

Results QC Date

April 28, 2010

Last Update Submit

April 30, 2014

Conditions

HyponatremiaEuvolemiaHypervolemia

Keywords

HyponatremiaEuvolemiaHypervolemiaConivaptanVaprisol®YM087

Outcome Measures

Primary Outcomes (1)

  • Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2

    Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion. One ISRMS has been reported for each participant \& represents the most severe state of ISR for that participant. ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis

    48 hours

Secondary Outcomes (5)

  • Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period

    Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment

  • Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours

    24.5 hours, 48.5 hours and 96.5 hours

  • Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period

    48.5 hours

  • Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours

    0-24.5 hours, 0-48.5 hours and 0-96.5 hours

  • Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours

    0-24.5 hours, 0-48.5 hours and 0-96.5 hours

Study Arms (4)

Dose Regimen 1

EXPERIMENTAL

Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule

Drug: ConivaptanDrug: placebo

Dose Regimen 2

EXPERIMENTAL

Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule

Drug: Conivaptan

Dose Regimen 3

EXPERIMENTAL

Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag

Drug: ConivaptanDrug: placebo

Dose Regimen 4

EXPERIMENTAL

Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag

Drug: Conivaptan

Interventions

ConivaptanDRUG

ampoule or premix bag

Also known as: YM087, Vaprisol
Dose Regimen 1Dose Regimen 2Dose Regimen 3Dose Regimen 4
placeboDRUG

ampoule or premix bag

Dose Regimen 1Dose Regimen 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a serum sodium value between 115 and 133 mEq/L
  • Subject is euvolemic or hypervolemic

You may not qualify if:

  • Clinical evidence of volume depletion or dehydration
  • Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Bangalore, 560034, India

Location

Unknown Facility

Bangalore, 560099, India

Location

Unknown Facility

Bhopal, 462001, India

Location

Unknown Facility

Hyderabaad, 500482, India

Location

Unknown Facility

Karnāl, 132001, India

Location

Unknown Facility

Afula, 18101, Israel

Location

Unknown Facility

Ashkelon, 78308, Israel

Location

Unknown Facility

Haifa, 31048, Israel

Location

Unknown Facility

Haifa, 34362, Israel

Location

Unknown Facility

Holon, 58100, Israel

Location

Unknown Facility

Jerusalem, 910301, Israel

Location

Unknown Facility

Jerusalem, 91120, Israel

Location

Unknown Facility

Rehovot, 76100, Israel

Location

Unknown Facility

Safed, 13100, Israel

Location

Unknown Facility

Tel Aviv, 64239, Israel

Location

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

Unknown Facility

Ẕerifin, 70300, Israel

Location

Related Publications (1)

  • Kalra S, Efrati S, Arthur JM, Oliven A, Velez JC, McNutt BE, Klasen S, Abeyratne A. Effect of loading dose and formulation on safety and efficacy of conivaptan in treatment of euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 Apr 1;68(7):590-8. doi: 10.2146/ajhp100243.

    PMID: 21411800BACKGROUND

Related Links

MeSH Terms

Conditions

HyponatremiaEdema

Interventions

conivaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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 Medial Director, Medical Affairs
Organization
Astellas Pharma Global Development
clinicaltrials@us.astellas.com

Study Officials

  • Art Wheeler, MD

    Cumberland Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

May 15, 2014

Results First Posted

May 26, 2010

Record last verified: 2014-04

Locations

IN(5)US(1)IL(12)