Trial · NCT00770653
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol. | Baseline and Week 24. | Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High-Density Lipoprotein Cholesterol. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Triglycerides. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Low-Density Lipoprotein Subfractions. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Low-Density Lipoprotein Cholesterol. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Intact Proinsulin. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Glucose. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Adiponectin. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | μg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (Original). | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L). | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/L | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Diastolic Blood Pressure. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Intake of Study Medication Greater Than 80% and Less Than 120%. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | participants | NUMBER |
| SECONDARY | Change From Baseline in Nitrotyrosine. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination. | nmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Soluble CD40 Ligand. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination. | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Matrix Metallo Proteinase-9. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination. | ng/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Soluble Intracellular Adhesion Molecule. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination. | ng/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Soluble Vascular Cell Adhesion Molecule. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination. | ng/mL | 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.
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