Trial · NCT03513549
Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
NCT03513549, Suspended, Alexza Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder. Trials, record NCT03513549. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03513549
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
- NCT number
- NCT03513549
- Status
- Suspended
- Enrollment
- 10,000 participants, estimated
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Conditions
- Agitation,Psychomotor
- Interventions
- Loxapine 10 MG
- First posted
- 2018-05-01
- Last updated
- 2025-10-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluating frequency and nature of adverse events, serious adverse events and respiratory adverse events of special interest (AESIs) after administration of ADASUVE treatment in real-world clinical settings | 24 hours | Safety will be assessed by evaluating adverse events, serious adverse events, and respiratory AESIs within the study follow-up period after administration of ADASUVE treatment in real-world clinical settings. |
| Secondary | Patient demographics | 24 hours | The secondary measure of this study is patient characteristics, including demographic characteristics, after administration of ADASUVE treatment in real-world clinical settings. |
| Secondary | Patient baseline characteristics - medical history | 24 hours | The secondary measure of this study is patient characteristics, including baseline characteristic of medical history, after administration of ADASUVE treatment in real-world clinical settings. |
| Secondary | Patient baseline characteristics - prior medications | 24 hours | The secondary measure of this study is patient characteristics, including baseline characteristic of prior medications, after administration of ADASUVE treatment in real-world clinical settings. |
| Other | Exploratory objective - patient treatment satisfaction | 24 hours | The exploratory objective of the study is to assess patient perception of effectiveness (ranging from extremely dissatisfied to extremely satisfied), convenience (ranging from extremely inconvenient to extremely convenient), and overall satisfaction (ranging from extremely dissatisfied to extremely satisfied) using a modified Treatment Satisfaction Questionnaire for Medication (TSQM) after administration of ADASUVE treatment in real-world clinical settings. The TSQM is a modified version of the original TSQM version 1.4, a widely used generic measure to assess treatment satisfaction with medication. Scores range from 0 to 100, with higher scores representing higher satisfaction. |
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/NCT03513549
GET https://conductscience.org/api/trials/v1/NCT03513549/registered