Trial · NCT00456521
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-primary: Body Weight- Mean Percent Change | Baseline, 56 weeks | Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percentage of body weight | LEAST_SQUARES_MEAN |
| PRIMARY | Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Body Weight- Proportion of Subjects With ≥10% Decrease | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Change in Waist Circumference | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Triglycerides Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Insulin Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting HDL Cholesterol Levels | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in IWQOL-Lite Total Scores | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in HOMA-IR Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Blood Glucose Levels | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting LDL Cholesterol | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Systolic Blood Pressure | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Diastolic Blood Pressure | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in IDS-SR Total Scores | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Food Craving Inventory Sweets Subscale Scores | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Food Craving Inventory Carbohydrates Subscale Scores | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00456521/outcomes