Trial · NCT01097616
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1 | Baseline and Week 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1 | Baseline and Night 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1 | Baseline and Week 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase | Up to 3 months | All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication | participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase | Up to 3 months | All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication | participants | NUMBER |
| SECONDARY | Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1 | Baseline and Night 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. | minutes | LEAST_SQUARES_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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01097616/outcomes