Transthyretin Amyloidosis
Conditions
Brief summary
1. Time to development of ATTR (ATTR-CM or ATTR-PN, whichever occurs first). For further details, please refer to the protocol.
Detailed description
1. Time to development of ATTR-CM and ATTR-PN. For further details, please refer to the protocol., 2. Participants who develop ATTR as defined in the primary endpoint at the time of study completion (yes/no), 3. Time to development of symptomatic ATTR and ATTR-CM, 4. Participants who develop symptomatic ATTR, 5. Proportion of participants with: treatment-emergent AEs and SAEs, AEs leading to treatment discontinuation, abnormal physical examination findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal ECG parameters of clinical relevance, changes in clinical safety laboratory parameters of potential concern
Interventions
DRUGAcoramidis Hydrochloride Matching Placebo
Sponsors
Eidos Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to development of ATTR (ATTR-CM or ATTR-PN, whichever occurs first). For further details, please refer to the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to development of ATTR-CM and ATTR-PN. For further details, please refer to the protocol., 2. Participants who develop ATTR as defined in the primary endpoint at the time of study completion (yes/no), 3. Time to development of symptomatic ATTR and ATTR-CM, 4. Participants who develop symptomatic ATTR, 5. Proportion of participants with: treatment-emergent AEs and SAEs, AEs leading to treatment discontinuation, abnormal physical examination findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal ECG parameters of clinical relevance, changes in clinical safety laboratory parameters of potential concern | — |
Countries
Belgium, Bulgaria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden
Outcome results
None listed