CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Everolimusdrug
Likely dose
Everolimus 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03525834
NCT03525834Phase 4Completed
CompareCT.gov

Phase IV, Single Arm Study of Safety and Efficacy of Everolimus in Chinese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma Not Requiring Immediate Surgery

Novartis Pharmaceuticals·interventional·Posted May 16, 2018·Updated Sep 9, 2021

In Brief

A Phase 4 clinical trial evaluating Everolimus for Renal Angiomyolipoma. Completed, enrolled 40 participants across 5 sites.

Detailed Summary

The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Angiomyolipoma
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 16, 2018
Enrollment StartNov 9, 2018
Primary CompletionSep 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.1 years ago

Interventions

Everolimusdrug

Everolimus 2.5 mg and 5 mg tablets with dosage regimen of 10 mg orally once daily.