Trial · NCT02858362
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg Muscles | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). | Percentage of fat in the muscle | MEAN |
| PRIMARY | Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg Muscles | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). | Milliseconds | MEAN |
| PRIMARY | Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3) | Pre-dose at Weeks 1, 4, 8, 12, 24, 36 and 48 | All participants in Cohorts 1 or 2 who received at least one dose of study medication and had at least one concentration measurement (which could be below the limit of quantification). No evaluable data was collected from Cohort 3 participants due to early study termination. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Simulated Maximum Plasma Concentration (Cmax) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3) | Pre-dose and 3 to 10 hours post-dose at Weeks 1, 4, 8, 12, 24, 36 and 48 | All participants in Cohorts 1 or 2 who received at least one dose of study medication and had at least one concentration measurement (which could be below the limit of quantification). No evaluable data was collected from Cohort 3 participants due to early study termination. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Simulated Average Plasma Concentration (Cav) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3) | Pre-dose and 3 to 10 hours post-dose at Weeks 1, 4, 8, 12, 24, 36 and 48 | All participants in Cohorts 1 or 2 who received at least one dose of study medication and had at least one concentration measurement (which could be below the limit of quantification). No evaluable data was collected from Cohort 3 participants due to early study termination. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | Day 1 to a maximum of Week 96 | All participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Utrophin Intensity | Baseline, Week 24 and Week 48 | All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). For the summaries of changes from baseline only those participants in this population who had measurements at both baseline and the relevant post-baseline visit were included. | Arbitrary units | MEAN |
| SECONDARY | Change From Baseline in Developmental Heavy Chain Myosin (MHCd) Expression | Baseline, Week 24 and Week 48 | All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). For the summaries of changes from baseline only those participants in this population who had measurements at both baseline and the relevant post-baseline visit were included. | Percent of muscle fibres expressing MHCd | MEAN |
| SECONDARY | Change From Baseline in Muscle Fibre Diameter | Baseline, Week 24 and Week 48 | All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). For the summaries of changes from baseline only those participants in this population who had measurements at both baseline and the relevant post-baseline visit were included. | Micrometers (μm) | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | Percentage of FEV1 | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | Percentage of FVC | MEAN |
| SECONDARY | Change From Baseline in Maximum Inspiratory Pressure (MIP) | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | cm H2O | MEAN |
| SECONDARY | Change From Baseline in Maximum Expiratory Pressure (MEP) | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | cm H2O | MEAN |
| SECONDARY | Change From Baseline in Peak Expiratory Flow (PEF) | Baseline, Week 12, Week 24, Week 36 and Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | Percentage of PEF | MEAN |
| SECONDARY | Change From Baseline in Peak Cough Flow (PCF) | Baseline, Week 12, Week 24, Week 36 and Week 48 | No evaluable data was collected from Cohort 3 participants due to early study termination. | ||
| SECONDARY | Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) | Baseline, Week 12, Week 24, Week 36 and Week 48 | No evaluable data was collected from Cohort 3 participants due to early study termination. | ||
| SECONDARY | Number of Participants That Experienced a Clinically Significant Change in Vital Signs Measurements | Baseline to Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Experienced a Clinically Significant in Physical Examination Result | Day 1 to Week 48 | All participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Experienced a Potentially Clinically Significant Electrocardiogram Measurements | Baseline to Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Experienced a Potentially Clinically Significant Echocardiogram Measurement | Baseline, Week 24 and Week 48 | All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT02858362/outcomes