A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

This study has been completed.

Study NCT00435591 Information provided by Astellas Pharma Inc

First Received on February 14, 2007. Last Updated on April 15, 2011 History of Changes

Results First Received: April 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Hyponatremia Euvolemia Hypervolemia
Interventions:	Drug: Conivaptan Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Dose Regimen 1	Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
Dose Regimen 2	Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
Dose Regimen 3	Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
Dose Regimen 4	Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag

Participant Flow: Overall Study

	Dose Regimen 1	Dose Regimen 2	Dose Regimen 3	Dose Regimen 4
STARTED	30	31	30	30
Safety Analysis Set	28	30	30	29
Full Analysis Set	28	29	30	29
End of Treatment	25	27	27	23
COMPLETED	23	27	25	19
NOT COMPLETED	7	4	5	11

Baseline Characteristics

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Reporting Groups

	Description
Dose Regimen 1	Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
Dose Regimen 2	Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
Dose Regimen 3	Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
Dose Regimen 4	Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag

Baseline Measures

	Dose Regimen 1	Dose Regimen 2	Dose Regimen 3	Dose Regimen 4	Total
Number of Participants [units: participants]	28	30	30	29	117
Age ^[1] [units: years] Mean ± Standard Deviation	59.1 ± 20.28	61.1 ± 20.14	64.8 ± 14.13	63.3 ± 22.31	62.1 ± 19.28
Gender ^[1] [units: participants]
Female	14	13	16	18	61
Male	14	17	14	11	56
Race/Ethnicity, Customized ^[1] [units: Participants]
White	14	16	14	16	60
Black/ African -American	0	1	0	0	1
Asian	14	13	15	13	55
American Indian / Alaskan	0	0	1	0	1
Volume Status/ Underlying Cause of Hyponatremia ^[2] [units: Participants]
Euvolemic/ SIADH	15	11	11	9	46
Euvolemic/ CHF	1	0	0	0	1
Euvolemic/ Malignancy	0	1	3	0	4
Euvolemic/ Idiopathic	0	1	1	2	4
Euvolemic/ COPD	1	0	0	0	1
Euvolemic/ Unknown	6	8	8	10	32
Euvolemic/ Other	2	7	4	6	19
Hypervolemic/ SIADH	0	0	1	0	1
Hypervolemic/ CHF	3	2	0	2	7
Hypervolemic/ Unknown	0	0	2	0	2

[1]	Population represented is Safety Analysis Set (SAF)
[2]	Population represented is Safety Analysis Set (SAF) SIADH: Syndrome of inappropriate antidiuretic hormone secretion CHF: Congestive heart failure COPD: Chronic obstructive pulmonary disease

[1]

Population represented is Safety Analysis Set (SAF)

[2]

Population represented is Safety Analysis Set (SAF)

SIADH: Syndrome of inappropriate antidiuretic hormone secretion CHF: Congestive heart failure COPD: Chronic obstructive pulmonary disease

Outcome Measures

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1. Primary:

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 [ Time Frame: 48 hours ]

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2. Secondary:

Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period [ Time Frame: Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment ]

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3. Secondary:

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 [ Time Frame: 24.5 hours, 48.5 hours and 96.5 hours ]

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4. Secondary:

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 [ Time Frame: 48.5 hours ]

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5. Secondary:

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 [ Time Frame: 0-24.5 hours, 0-48.5 hours and 0-96.5 hours ]

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6. Secondary:

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 [ Time Frame: 0-24.5 hours, 0-48.5 hours and 0-96.5 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site’s manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Senior Medial Director, Medical Affairs
Organization: Astellas Pharma Global Development
e-mail: clinicaltrials@us.astellas.com

Publications:

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.

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier:	NCT00435591 History of Changes
Other Study ID Numbers:	087-CL-084
Study First Received:	February 14, 2007
Results First Received:	April 28, 2010
Last Updated:	April 15, 2011
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health; India: Drugs Controller General of India