Trial · NCT01455012
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | Nocturnal Elevations of Systolic BP | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | Nocturnal Elevations of Systolic BP | MEAN |
| SECONDARY | Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | Periodic Limb Movements/hour | MEAN |
| SECONDARY | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | participants | NUMBER |
| SECONDARY | Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | participants | NUMBER |
| SECONDARY | Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | participants | NUMBER |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01455012/outcomes