Trial · NCT01009060
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512 | Baseline and up to Week 7 | ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7 | Baseline and Week 7 | ITT Population. Only those participants available at the indicated time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7 | Baseline and Week 7 | ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7 | Baseline and Week 7 | ITT Population. Only those participants at indicated time point were analyzed. | T-scores | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7 | Baseline and Week 7 | ITT Population. Only those participants available at the indicated time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7 | Baseline and Week 7 | ITT Population. Only those participants available at the indicated time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7 | Baseline and Week 7 | ITT Population. Only those participants available at the indicated time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 59 | Safety Population consisted of all randomized par. who took at least one dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings | Up to Day 59 | Safety Population. Only those participants who showed most severe on-treatment abnormal ECG findings are presented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range | Up to Day 59 | Safety Population. Only those par. available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range | Up to Day 59 | Safety Population. Only those par. available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment | Up to Day 59 | Safety Population. Only those par. available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment | Up to Day 59 | Safety Population. Only those par. available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern | Up to Day 59 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment | 15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7 | PK-concentration population included all par. for whom a PK sample was obtained and analyzed. Number of units analyzed are number of samples available for analysis. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
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.
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