Trial · NCT04589130
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percentage Change in Body Weight | Week 0 to Week 28 | To determine the weight loss maintenance and any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population. |
| Primary | Percentage of participants who maintained their weight | Week 0 to Week 28 | To determine the weight loss maintenance effect of Contrave with usual care compared to placebo with usual care, in post behaviour modification program population (Participants who had a weight regain less than or equal to 3% of weight from Week 0 - 28 will be regarded as maintainers). |
| Primary | Percentage of participants who lost more than of equal to 5% of body weight | Week 0 to Week 28 | To determine any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population. |
| Secondary | Mean Percentage Change in Body Weight from baseline to week 52 | Week 0 to Week 52 | To determine the weight loss maintenance and any further weight loss effect of Contrave compared to placebo, in a post behaviour modification program population. |
| Secondary | Percentage of participants who maintained their weight | Week 0 to Week 52 | To determine the weight loss maintenance effect of Contrave compared to placebo, in a post behaviour modification program population (Participants who had a weight regain less than or equal to 3% of weight from Week 0 - 52 will be regarded as maintainers). |
| Secondary | Percentage of participants who lost more than or equal to 5% of body weight | Week 0 to Week 52 | To determine any further weight loss effect of Contrave compared to placebo, in a post behaviour modification program population. |
| Secondary | Percentage of participants who lost more than or equal to 10% of body weight | Week 0 to Week 28 and Week 52 | To determine any further weight loss effect of Contrave compared to placebo, in a post behaviour modification program population. |
| Secondary | Percentage of participants with weight regain (≥ 5% from baseline) | Week 0 to Week 28 and Week 52 | To determine any weight regain in participants taking Contrave compared to placebo, in a post behaviour modification program population. |
| Secondary | Percentage of subjects with weight regain (≥ 10% from baseline) | Week 0 to Week 28 and Week 52 | To determine any weight regain in participants taking Contrave compared to placebo, in a post behaviour modification program population. |
| Secondary | Mean Percentage Change in Body Weight in participants who crossed over from placebo to Contrave | Week 28 to Week 52 | To determine any weight loss or maintenance effect of Contrave following placebo control phase. |
| Secondary | Change in blood pressure (both systolic and diastolic) | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on hypertensive control, in a post behaviour modification program population. |
| Secondary | Change in fasting lipid profile | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on total cholesterol, triglycerides, HDL and LDL, in a post behaviour modification program population. |
| Secondary | Change in fasting blood glucose | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on diabetes control, in a post behaviour modification program population. |
| Secondary | Changes in impulsivity behaviours from baseline as assessed by UPPS-P Impulsive Behaviour Scale (self administered questionnaire) | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on impulsivity behaviours, in a post behaviour modification program population. Urgency, Premeditation (lack of), Perserverance (lack of), Sensation Seeking, Positive Urgency (UPPS-P Impulsive Behaviour Scale) |
| Secondary | Changes in quality of life and health economic outcomes. | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on quality of life and health economic outcomes, in a post behaviour modification program population. Assessed by EQ-5D-5L questionnaire. |
| Secondary | Percentage of participants who are adherent to pharmacotherapy | Week 0 to Week 28 and Week 52 | To determine the tolerability of Contrave compared to placebo, in a post behaviour modification program setting. |
| Secondary | Average number of days participants took investigational product (Contrave or placebo) | Week 0 to Week 28 and Week 52 | To determine the tolerability of Contrave compared to placebo, in a post behaviour modification program setting. |
| Secondary | Change in heart rate | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on heart rate, in a post behaviour modification program population. |
| Secondary | Change in HbA1c | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on diabetes control, in a post behaviour modification program population. |
| Secondary | Changes in eating behaviours from baseline as assessed by Eating Disorder Examination Questionnaire (EDE-Q 6.0) (self administered questionnaire) | Week 0 to Week 28 and Week 52 | To determine the effect of Contrave compared to placebo on eating behaviours, in a post behaviour modification program population. |
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/NCT04589130/registered