Trial · NCT00392925
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population | Baseline to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Participants excluded from the Evaluable Population were identified prior to the unblinding process. n=number with non-missing body weight data at Week 16 in each treatment group. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Baseline up to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population | Baseline to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Enrollment to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Enrollment to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population | Baseline to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. | kg/week | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population | Baseline to Weeks 16 and Weeks 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | participants | NUMBER |
| SECONDARY | LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population | Enrollment to Baseline | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. Number with non-missing body weight data at Day 1 of Randomization were analyzed. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population | Enrollment to Week 20 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population | Baseline to Week 20 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population | Screening up to Week 20 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Those excluded from the Evaluable Population were identified prior to the unblinding process. Number with non-missing anthropometric data in each treatment group were analyzed. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population | Enrollment up to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 16. | participants | NUMBER |
| SECONDARY | Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population | Enrollment up to Week 20 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 20 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 20. | participants | NUMBER |
| SECONDARY | Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data for lipids and glucose in each treatment group. | mg/dL | MEAN |
| SECONDARY | Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. | ng/mL | MEAN |
| SECONDARY | Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number analyzed with non-missing data at visit. | pM | MEAN |
| SECONDARY | Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. | µIU/mL | MEAN |
| SECONDARY | LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. (POMS)n=19, 38, 36; (IWQOL-Lite)n=19, 38, 36 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population | Enrollment to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number with non-missing data in each treatment group were analyzed (n). | units on a scale | 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
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GET https://conductscience.org/api/trials/v1/NCT00392925/outcomes