Trial · NCT01556763
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. | Screening (Day -5 for continuous cardiac monitoring) to Day 22 | Safety and tolerability was measured by number of reported adverse events (serious and non-serious) and repeated clinical evaluation of physical examinations, vital signs, 12-lead electrocardiogram (ECG), 24-hour continuous cardiac monitoring, and laboratory tests (hematology/blood chemistry/urinalysis). |
| Primary | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole | Days 1 and 21 | Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Primary | EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone | Days 1 and 21 | Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21. |
| Secondary | N100 Gating Ratio | Days -1 to 20 | N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value. |
| Secondary | P50 Amplitude Difference | Days -1 to 20 | P50 auditory evoked potential response (amplitude measured in microvolts) using sensory gating paradigm. Measured by EEG as amplitude difference (conditioning stimulus minus test stimulus). Plotted on a scale of -0.2 to 0.8 microvolts. Normalization is suggested by a higher value. |
| Secondary | MMN Summed Amplitude | Days -1 to 20 | Mismatch negativity (MMN) auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the voltage difference over 100-200 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -1.2 to 0.2 microvolts. Normalization is suggested by a more negative value. |
| Secondary | P300 Peak Amplitude | Days -1 to 20 | P300 auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the peak amplitude over 250-500 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -0.4 to 1.2 microvolts. Normalization is suggested by a more positive value. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01556763/registered