Trial · NCT00658372
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. | 8 weeks | |
| Primary | The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study | 8 weeks | |
| Secondary | Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score | 8 weeks | |
| Secondary | Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 | 6 weeks | |
| Secondary | Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales | 8 weeks | |
| Secondary | Response rate on the patient-rated PGI-C at week 8 | 8 weeks | |
| Secondary | The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit) | 1 week | |
| Secondary | Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) | 8 weeks | |
| Secondary | Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score | 8 weeks | |
| Secondary | Response rate on the HAM-A at week 1 and week 8 | 8 weeks | |
| Secondary | Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score | 1 week | |
| Secondary | Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 | 8 weeks | |
| Secondary | Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 | 8 weeks | |
| Secondary | Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) | 8 weeks | |
| Secondary | Change from baseline to week 8 in the QLesQ General Activity Score | 8 weeks | |
| Secondary | Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) | 8 weeks | |
| Secondary | Remission rate based on the HAM A at Week 8 | 8 weeks | |
| Secondary | Response rate on the clinician-rated CGI-I ate week 1 and week 8 | 8 weeks | |
| Secondary | Change from baseline in CGI-S at week 8 | 8 weeks | |
| Secondary | Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) | 8 weeks |
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/NCT00658372/registered