Tolvaptan in Hyponatremic Cancer Patients
|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|
|Primary Completion Date :||September 2013|
|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).
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|