Trial · NCT03452488
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | Baseline and 6 Months | Full Analysis Set: The Full Analysis Set (FAS) population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included.~One participant randomized but not treated with 175 mg BIO101. | Meter/Second (m/s) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Short Form-36 (SF-36) 10 Item Physical Function Domain (PF-10) Sub-score | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Handgrip Strength Test | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | kilograms (Kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Appendicular Lean Body Mass (ALM) Based on Dual-energy X-ray Absorptiometry (DEXA) Measurements | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Kg | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Response for Completing 400 MW Test After 6 Months | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with rate of response for completing 400 MW test were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to 6 Months in Muscle Strength Based on Knee Extension | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. This data represents Knee Extension of Highest Reading from all Degrees. Participants with data available were included. | Newton meter (Nm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Time for Five Chair Stands as Part of the Short Physical Performance Battery (SPPB) Assessment | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Distance in the 6-Minute Walk Test (6MWT) | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Meters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Pepper Assessment Tool for Disability (PAT-D) for Obese Participants | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in SPPB Total Score | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Sarcopenia Quality of Life (SarQoL) Auto-Evaluation Questionnaire | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. This data represents overall disability score. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Stair Climb Power Test (SCPT) | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Seconds | 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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GET https://conductscience.org/api/trials/v1/NCT03452488/outcomes