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Tolvaptan in Hyponatremic Cancer Patients

NCT01199198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-09-23

Study results available
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Summary

The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.

Conditions

Interventions

DRUG

Tolvaptan

Starting dose 15 mg by mouth once a day for 14 days.

DRUG

Placebo

Placebo by mouth once a day for 14 days.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Abdulla K. Salahudeen, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199198 on ClinicalTrials.gov