Trial · NCT00784654
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period. | percentage of participants | NUMBER |
| SECONDARY | Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period | Open-label baseline and Endpoint (Week-26) | Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period. | Scores on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized FAS | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period | At Week 26 | Open-label FAS | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percent of Participants With CGI-S at Open-label Baseline | Open-label baseline | Open-label FAS | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF) | At endpoint of the randomized withdrawal period (Up to 6 weeks) | Randomized FAS | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period | At Week 26 | Open-label FAS | percentage of improved participants | NUMBER |
| SECONDARY | Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF | At open-label baseline and endpoint (Week-26) of the open-label period | Open-label FAS | scores on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized FAS | Scores on a scale | MEAN |
| SECONDARY | Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period | At open-label baseline and endpoint (Week-26) of the open-label period | Open-label FAS | T-scores | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized FAS | T-scores | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period | At open-label baseline and endpoint (Week-26) of the open-label period | Open-label FAS | scores on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized FAS | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period | At open-label baseline and endpoint (Week-26) of the open-label period | Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period. | Scores on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period | Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks) | Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Percent of Participants With CGI-S at Randomized Withdrawal Baseline | Randomized withdrawal baseline | Randomized FAS | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period | From open-label baseline to Week-26 | Open-label Safety Population | participants | NUMBER |
| OTHER_PRE_SPECIFIED | C-SSRS During the Randomized Withdrawal Period | Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks) | Randomized Safety Population | participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00784654/outcomes