Yes — results are overdue. Primary completion was 2018-04-09; the FDAAA-801 reporting deadline (2019-04-09) passed 2676 days ago and no results are posted on ClinicalTrials.gov.
| NCT ID | NCT01231594 ↗ |
|---|---|
| Sponsor | Novartis Pharmaceuticals (INDUSTRY) |
| Public issuer | NOVARTIS AG — NVS (CIK 0001114448) best-effort name match, 95% conf — verify on EDGAR ↗ |
| Phase | PHASE1 |
| Status | COMPLETED |
| Primary completion | 2018-04-09 (ACTUAL) |
| Reporting deadline | 2019-04-09 (completion + 365d) |
| Days overdue | 2676 |
| Results posted | No — check results tab ↗ |
| FDA-regulated | drug: yes, device: no |
| Provenance | Flagged overdue on 2026-06-21 · SHA-256 3d087907377f6947… (hash-chained, tamper-evident) |
Source of record: ClinicalTrials.gov NCT01231594. The reporting requirement is FDAAA 801 (Public Law 110-85 §801) and the Final Rule, 42 CFR Part 11.