drugset / Trial / NCT04147871
Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter, randomized, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability, and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children.
Timeline
- Start
- 2024-03-01
- Primary completion
- 2025-05-01
- Completion
- 2025-06-01
Outcome
Outcome not reported
Stopped (Business): “Unspecified business decision/strategic reason”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ADV7103 | Unknown | 1.5 meq | — |
| Comparator | ADV7103 | Unknown | 3 meq | — |
| Comparator | ADV7103 | Unknown | 4.5 meq | — |