Trial · NCT03179631
Outcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Period: Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 72 - Modified Intention-to-treat (mITT) Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | meters | LEAST_SQUARES_MEAN |
| PRIMARY | DB Period: Change From Baseline in 6MWD at Week 72 - Intent-to-Treat (ITT) Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | meters | LEAST_SQUARES_MEAN |
| PRIMARY | DB Period: Average Rate of Change From Baseline in 6MWD at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | meters/week | LEAST_SQUARES_MEAN |
| PRIMARY | DB Period: Average Rate of Change From Baseline in 6MWD at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | meters/week | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Time to Run/Walk 10 Meters at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Time to Run/Walk 10 Meters at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Time to Climb 4 Stairs at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Time to Climb 4 Stairs at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Time to Descend 4 Stairs at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Time to Descend 4 Stairs at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Composite of Average Change From Baseline in TFTs at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Composite of Average Change From Baseline in TFTs at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Composite of Average Rate of Change From Baseline in TFTs at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | seconds/week | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Composite of Average Rate of Change From Baseline in TFTs at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds/week | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Time to Persistent 10% Worsening in 6MWD at Week 72 - mITT Population | Baseline to Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. Here, 'Overall number of participants analyzed' = participants with 10% persistent worsening by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Time to Persistent 10% Worsening in 6MWD - ITT Population | Baseline to approximately Week 72 (Due to COVID, many participants attended the protocol-defined Week 72 visit late) | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. 'Overall number of participants analyzed' = participants with 10% persistent worsening by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Change From Baseline in North Start Ambulatory Assessment (NSAA) Total Score at Week 72 - mITT Population | Baseline, Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in NSAA Total Score at Week 72 - ITT Population | Baseline, Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Time to Loss of Ambulation - mITT Population | Baseline up to approximately Week 72 (Due to COVID, many participants attended the protocol-defined Week 72 visit late) | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. Here, 'Overall number of participants analyzed' = participants with loss of ambulation by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Time to Loss of Ambulation Over 72 Weeks - ITT Population | Baseline up to Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants with loss of ambulation by Week 72. | weeks | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03179631/outcomes