Trial · NCT04057937
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieve a PPPASI-50 at Week 16 | At Week 16 | Intent-to-treat (ITT) population which includes all randomized participants who received at least one dose of investigational product. | Percentage of Partcipants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Weeks 2 to 14 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Weeks 2 to 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Percentage of Partcipants | NUMBER |
| SECONDARY | Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16 | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Scores * Day | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Percent Change | MEAN |
| SECONDARY | Change From Baseline in PPPASI Total Score at Week 16 | Baseline and Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | AUC for PPSI Total Score From Baseline Through Week 16 | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Scores * Day | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Percent Change | MEAN |
| SECONDARY | Change From Baseline in PPSI Total Score at Week 16 | Baseline and Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Weeks 2 to 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with a PGA greater than 1 at baseline are included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Weeks 2 to 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with a PGA greater than 1 at baseline are included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Baseline and Weeks 2,4,6,8,12,16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Units on scale | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04057937/outcomes