Trial · NCT04369391
A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
NCT04369391, Phase 1, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia. Trials, record NCT04369391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04369391
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
- NCT number
- NCT04369391
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 150 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- SEP363856 150 mg, Placebo, moxifloxacin 400 mg
- First posted
- 2020-04-30
- Last updated
- 2024-06-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Placebo-adjusted change-from-baseline QTc interval (ΔΔQTc) | 24 Hours | |
| Secondary | Change from baseline in heart rate, QTcF, pulse rate, and QRS intervals (∆HR, ΔQTcF, ΔPR, and ∆QRS) | 24 Hours | |
| Secondary | If a substantial heart rate (HR) effect is observed: Change from baseline in QTcS, QTcI, and QTcP (ΔQTcS, ΔQTcI, and ΔQTcP) | 24 Hours | |
| Secondary | Placebo-adjusted change from baseline in heart rate, pulse rate, and QRS intervals (ΔΔHR, ΔΔPR, and ΔΔQRS) | 24 Hours | |
| Secondary | If a substantial heart rate (HR) effect is observed: Placebo-adjusted ΔQTcS, and/or ΔQTcI, and/or ΔQTcP, and/or ΔQTcF (ΔΔQTcS, ΔΔQTcI, ΔΔQTcP, ΔΔQTcF) if not selected as the primary endpoint | 24 Hours | |
| Secondary | Categorical summary for QTcF, heart rate, pulse rate, and QRS intervals | 24 Hours | |
| Secondary | If a substantial heart rate (HR) effect is observed: Categorical summary for QTcS, QTcI, and QTcP | 24 Hours | |
| Secondary | Frequency of treatment-emergent changes of T-wave morphology and U-waves presence. | 24 Hours |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04369391
GET https://conductscience.org/api/trials/v1/NCT04369391/registered