Trial · NCT00673387
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Baseline to Week 28 | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | Percentage change in kg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Baseline to Week 28 | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | participants | NUMBER |
| SECONDARY | Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population | Baseline to Week 28 | Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented. | ng/mL | MEAN |
| SECONDARY | LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population | Baseline to Week 28 | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population | Baseline to Weeks 12 and Week 28 | Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Week 4 and Week 24 | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36. | pg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide | Weeks 4 and 24 | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively. | pg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Week 4 and Week 24 | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population | Baseline to Week 28 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | percentage of body fat | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population | Baseline to Week 28 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population | Baseline to Week 28 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population | Baseline to Week 28 | Evaluable population: received at least one dose of randomized treatment, had adequate exposure to treatment, complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) presented above for TC, LDL and HDL cholesterol. Glucose n= 43, 50, 41, 46, 45, 43,44,36; Triglycerides n= 44,50,41,46,45,44,44.38. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population | Baseline to Week 28 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. | µIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | units on a scale | MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | units on a scale | MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | units on a scale | MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | units on a scale | MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | units on a scale | MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | units on a scale | MEAN |
| SECONDARY | Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population | Screening to Week 24 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization. | 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
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GET https://conductscience.org/api/trials/v1/NCT00673387/outcomes