Trial · NCT01495169
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
NCT01495169, Phase 1, Completed, Vanda Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients. Trials, record NCT01495169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01495169
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
- NCT number
- NCT01495169
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 33 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Safety and Tolerability of Iloperidone
- Interventions
- iloperidone (oral tablet)
- First posted
- 2011-12-19
- Last updated
- 2016-06-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics of iloperidone at different dose levels based on AUC (area under the plasma concentration time curve during a dosage interval) Cmax ss (maximum plasma concentration at steady state), Tmax ss (time to Cmax at steady state). | Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level) | Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing. From the plasma concentration data, AUC, Cmax ss, and Tmax ss are calculated. |
| Primary | Tolerability of iloperidone at different dose levels | 14 days | Frequency of treatment emergent adverse events, frequency of clinically notable changes from baseline in vital signs, electrocardiograms, laboratory tests, and reponses on movement disorder rating scales (Barnes Akathisia Rating Scale, Simpson-Angus Scale) and on a rating scale for suicidal thoughts and behaviors (Columbia Suicide Severity Rating Scale) |
| Secondary | Number of Patients with Adverse Events, Serious Adverse Events or Death | 26 weeks | Safety and tolerability profile in open-label extension |
| Secondary | Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I) | Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks | The CGI-I is scored from 1 to 7 and assesses the overall degree of illness relative to baseline. A CGI-I rating of 4 is equivalent to "no change." Ratings less than 4 are equivalent to "improvement" and ratings of more than 4 are equivalent to "worsening." |
| Secondary | Change from baseline in the Children's Global Asessment Scale (CGAS | Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks | The CGAS) is a numeric scale (1 through 100) used to rate the general functioning of children; high scores indicate better functioning. |
| Secondary | Effect of iloperidone on QT, QT beat-to-beat (QTbtb), QT corrected using the Fridericia formulat (QTcF), QT corrected using the Bazett formula (QTcB), individual based correct QT (QTcI) | Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours | Patients wear a holter monitor for \~24 hours during the baseline period, for an additional 4 hours after the first dose, and for \~13 hours after they have been on the same dose for at least 7 days to compare how the heart beats before and after the study drug is taken. The holter monitor transmits continuous data to a computer on how the heart beats for the time when the monitor is on and is a better measurement than data collected by a traditional electrocardiogram (ECG), which provides data on a limited number of heart beats over a short period of time. |
| Secondary | Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate) | Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks | Three ECGs are obtained for each assessment. The values are averaged for each ECG parameter (QTcF, QTcB, QRS, PR interval, heart rateare) and clinically notable changes from baseline and new or worsening heart rhythm disorders are identified |
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/NCT01495169
GET https://conductscience.org/api/trials/v1/NCT01495169/registered