Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

This study has been completed.

Study NCT00478192 Information provided by Astellas Pharma Inc

First Received on May 22, 2007. Last Updated on May 26, 2011 History of Changes

Results First Received: March 31, 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
Condition:	Hyponatremia
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
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient in the Placebo arm discontinued prior to dosing and therefore was not included in the Full Analysis Set (FAS) or the Safety Analysis Set (SAF).

Reporting Groups

	Description
Regimen 1 Conivaptan QD	20 mg conivaptan once a day
Regimen 2 Conivaptan BID	20 mg conivaptan two times a day
Regimen 3 Placebo	No text entered.

Participant Flow: Overall Study

	Regimen 1 Conivaptan QD	Regimen 2 Conivaptan BID	Regimen 3 Placebo
STARTED	20	20	10
Full Analysis Set / Safety Analysis Set	20	20	9
End of Treatment	18	16	8
COMPLETED	16	15	8
NOT COMPLETED	4	5	2

Baseline Characteristics

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Reporting Groups

	Description
Regimen 1 Conivaptan QD	20 mg conivaptan once a day
Regimen 2 Conivaptan BID	20 mg conivaptan two times a day
Regimen 3 Placebo	No text entered.

Baseline Measures

	Regimen 1 Conivaptan QD	Regimen 2 Conivaptan BID	Regimen 3 Placebo	Total
Number of Participants [units: participants]	20	20	9	49
Age ^[1] [units: years] Mean ± Standard Deviation	58.6 ± 17.36	67.5 ± 14.70	61.8 ± 20.19	62.8 ± 17.01
Gender ^[1] [units: participants]
Female	7	11	8	26
Male	13	9	1	23
Race/Ethnicity, Customized ^[1] [units: participants]
Asian	7	4	3	14
Black or African American	1	1	2	4
White	12	15	4	31

[1]	Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug.

Outcome Measures

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1. Primary:

Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. [ Time Frame: Baseline and 48 hours ]

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2. Secondary:

Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment [ Time Frame: Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48 ]

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3. Secondary:

Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium [ Time Frame: 48 Hours ]

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4. Secondary:

Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours [ Time Frame: 48 Hours ]

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5. Secondary:

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 [ Time Frame: 48 Hours ]

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6. Secondary:

Baseline –Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours [ Time Frame: 48 Hours ]

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7. Secondary:

Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment [ Time Frame: Baseline, Hour 12, Hour 24,Hour 36 and Hour 48 ]

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8. Secondary:

Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment [ Time Frame: Baseline, Hour 24 and Hour 48 ]

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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 Medical Director, Medical Affairs
Organization: Astellas Pharma Global Development
e-mail: clinicaltrials@us.astellas.com

Publications:

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.

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier:	NCT00478192 History of Changes
Other Study ID Numbers:	087-CL-088
Study First Received:	May 22, 2007
Results First Received:	March 31, 2010
Last Updated:	May 26, 2011
Health Authority:	United States: Food and Drug Administration; India: Drugs Controller General of India