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NCT01199198 · ClinicalTrials.gov registry record · Phase 4
Tolvaptan in Hyponatremic Cancer Patients
A Phase 4 study of Advanced Cancers, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01199198: Completed Phase 4 study of Advanced Cancers, sponsored by M.D. Anderson Cancer Center.
NCT01199198 is a Phase 4 study of Advanced Cancers that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 52 participants, below the 65-participant average among 10 other Advanced Cancers trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01199198, a Phase 4 study of Advanced Cancers, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tolvaptan
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-09 |
| Phase | Phase 4 |
What the finished NCT01199198 record still lists
NCT01199198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 65-participant average among 10 other Advanced Cancers trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Advanced Cancers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01199198 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01199198 about?
NCT01199198 is a clinical study titled "Tolvaptan in Hyponatremic Cancer Patients". 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.
What is the current status of trial NCT01199198?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2011-05. Estimated completion is 2013-09.
What conditions does trial NCT01199198 study?
This clinical trial studies the following conditions: Advanced Cancers.
What interventions are being tested in trial NCT01199198?
The interventions under investigation include: Placebo (DRUG), Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT01199198?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01199198 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Cancers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01199198's enrollment target sits among peer trials
52 6th of 10 higher than 5 of 10 other Advanced Cancers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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