Trial · NCT02930655
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in blood pressure | Up to Week 12 | |
| Primary | Change from baseline in heart rate | Up to Week 12 | |
| Primary | Change from baseline in electrocardiogram (ECG) variables | Up to Week 12 | The duration (in ms) of the different ECG variables were measured using a standard 12-lead ECG |
| Primary | Change from baseline in body weight | Up to Week 12 | |
| Primary | Number of subjects with treatment-emergent adverse events and serious adverse events | Up to Week 12 | |
| Primary | Number of subjects with adverse events leading to premature discontinuation of lucerastat or ERT | Up to Week 12 | |
| Primary | Number of subjects with treatment-emergent abnormalities in laboratory variables | Up to Week 12 | |
| Secondary | Change from baseline in plasma biomarkers of Fabry Disease | Up to Week 12 | Biomarkers reflecting glycolipid metabolism were measured (unit of measure: ng/mL) |
| Secondary | Change from baseline in urine biomarker of Fabry Disease | Up to Week 12 | Biomarker reflecting glycolipid metabolism was measured (unit of measure: ng/mg) |
| Secondary | Change from baseline in left ventricular ejection fraction (LVEF) | Up to Week 12 | LVEF was used to monitor cardiac function in subjects with Fabry Disease |
| Secondary | Change from baseline in left ventricular mass index (LVMi) | Up to Week 12 | LVMi was used to monitor cardiac function in subjects with Fabry Disease |
| Secondary | Change from baseline in estimated glomerular filtration rate (eGFR) | Up to Week 12 | eGFR was used to monitor renal function in subjects with Fabry Disease |
| Secondary | Change from baseline in urine albumin-to-creatinine ratio (UACR) | Up to Week 12 | UACR was used to monitor renal function in subjects with Fabry Disease |
| Secondary | Maximum plasma concentration (Cmax) of lucerastat | At Week 4 visit, blood samples drawn at the following time points: pre-dose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h post-dose | Cmax was determined directly from the observed plasma concentration-time curves of lucerastat. Blood samples for PK analyses were drawn at scheduled time points at the Week 4 visit |
| Secondary | Time to reach Cmax (tmax) of lucerastat | At Week 4 visit, blood samples drawn at the following time points: pre-dose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h post-dose | tmax was determined directly from the observed plasma concentration-time curves of lucerastat. Blood samples for PK analyses were drawn at scheduled time points at the Week 4 visit |
| Secondary | Area under the plasma concentration-time curve [AUC(tau)] of lucerastat | At Week 4 visit, blood samples drawn at the following time points: pre-dose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h post-dose | AUC(tau) corresponds to the area under the plasma concentration time curve of lucerastat over a dosing interval (tau = 12 hours) |
| Secondary | Terminal half-life [t(1/2)]of lucerastat | At Week 4 visit, blood samples drawn at the following time points: pre-dose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h post-dose |
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/NCT02930655/registered