Trial · NCT01346072
Pilot Study of Using Copeptin to Predict Response to Tolvaptan
NCT01346072, Phase 4, Completed, University of North Carolina, Chapel Hill; results first posted 2017-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Using Copeptin to Predict Response to Tolvaptan. Trials, record NCT01346072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01346072
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Using Copeptin to Predict Response to Tolvaptan
- NCT number
- NCT01346072
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- Interventions
- tolvaptan
- First posted
- 2011-05-02
- Last updated
- 2017-05-17
- Results first posted
- 2017-05-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urine Output | 24 hours | Total urine output for 24 hours following tolvaptan administration |
| Primary | Body Weight | Change over 24 hours | Change in body weight from baseline to 24 hours after tolvaptan administration |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urine Output | 24 hours | All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis. | mL | MEAN |
| PRIMARY | Body Weight | Change over 24 hours | All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis. | Kg | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urine Output | Tolvaptan High Copeptin | 6498 | Standard Deviation 2328 | mL | |
| Urine Output | Tolvaptan Low Copeptin | 5784 | Standard Deviation 1835 | mL | |
| Body Weight | Tolvaptan High Copeptin | -1.3 | Standard Deviation 1.0 | Kg | |
| Body Weight | Tolvaptan Low Copeptin | -0.4 | Standard Deviation 1.0 | Kg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan High Copeptin | 11 | |
| Overall Study | STARTED | Tolvaptan Low Copeptin | 10 | |
| Overall Study | COMPLETED | Tolvaptan High Copeptin | 11 | |
| Overall Study | COMPLETED | Tolvaptan Low Copeptin | 10 | |
| Overall Study | NOT COMPLETED | Tolvaptan High Copeptin | 0 | |
| Overall Study | NOT COMPLETED | Tolvaptan Low Copeptin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan High Copeptin | 0 | 11 |
| Total, all-cause mortality | Tolvaptan Low Copeptin | 0 | 10 |
| Total, other adverse events | Tolvaptan High Copeptin | 0 | 11 |
| Total, other adverse events | Tolvaptan Low Copeptin | 0 | 10 |
| Total, serious adverse events | Tolvaptan High Copeptin | 0 | 11 |
| Total, serious adverse events | Tolvaptan Low Copeptin | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tolvaptan High Copeptin vs Tolvaptan Low Copeptin: deaths from any cause | Trial comparisons |
| Tolvaptan High Copeptin vs Tolvaptan Low Copeptin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01346072
GET https://conductscience.org/api/trials/v1/NCT01346072/registered