Trial · NCT00368745
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free | Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1) | Intent to Treat (ITT) population: received at least 1 dose pregabalin or placebo. Primary outcome ITT = all treated subjects in alprazolam free phase. Endpoint = Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6) | ITT; subject has a baseline and at least 1 post-baseline measurement before week 13; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores | Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | ITT; data not analyzed: PWC not measured at baseline. | ||
| SECONDARY | Number of Subjects With > = 5 New PWC Symptoms | Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | ITT; data not analyzed: PWC not measured at baseline. | ||
| POST_HOC | Mean Scores Physician's Withdrawal Checklist (PWC) | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 ) | ITT; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. Endpoint = AF Week 6 or LOCF. Refer to measure Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | ITT; Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores. | ||
| SECONDARY | Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | ITT; subject has a baseline and at least 1 post-baseline endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale | Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | ITT; subject has a baseline and endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Scores for Patient Global Impression-Improvement (PGI-I) | Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | ITT; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores | Baseline, Endpoint (AF Week 6 ) | ITT; subject has baseline and endpoint (final visit) measurement; endpoint = AF Week 6 or LOCF. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Discontinuation | Baseline, Week 13 (Final Visit/Early Termination) | ITT; Week 13 (Final Visit/Early Termination) or LOCF. | days | NUMBER |
| SECONDARY | Time to First Use of Rescue Medication | Baseline, Week 13 (Final Visit/Early Termination) | ITT; Week 13 (Final Visit/Early Termination) or LOCF | days | NUMBER |
| SECONDARY | Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6) | Alprazolam Free Week 6 | ITT; endpoint = AF Week 6 or LOCF. | 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/NCT00368745/outcomes