Tolvaptan in Hyponatremic Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01199198|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: Tolvaptan Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Tolvaptan Group
Tolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days.
Starting dose 15 mg by mouth once a day for 14 days.
Other Name: Samsca
Placebo Comparator: Placebo Group
Placebo Group: Placebo by mouth once a day for 14 days.
Placebo by mouth once a day for 14 days.
Other Name: Sugar Pill
- Proportion of Patients whose Serum Sodium Concentration Corrected to at least 135 mEq/L on Day 14 [ Time Frame: 14 days ]Compare proportion of hyponatremia cancer patients with a normalized serum sodium concentration at day 14 between those treated with Tolvaptan and those treated with a placebo (standard of care).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199198
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Abdulla K. Salahudeen, MD||UT MD Anderson Cancer Center|