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NCT00403416 · ClinicalTrials.gov registry record · Phase 1

Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
215
Enrollment target

NCT00403416: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT00403416 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 215 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (258% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00403416, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
215 participants
Enrollment target

Study Summary

This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

Interventions

  • DRUG AEB071
  • DRUG Mycophenolic Acid

Trial Details

FieldValue
Enrollment Target 215 participants
Start Date 2006-10
Est. Completion 2008-05
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00403416 record still lists

NCT00403416 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (258% higher).

The record links to 0 conditions, and to 2 interventions - of which AEB071 is the first listed.

NCT00403416 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00403416 about?

NCT00403416 is a clinical study titled "Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients". This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

What is the current status of trial NCT00403416?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 215 participants. The study started on 2006-10. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00403416?

The interventions under investigation include: AEB071 (DRUG), Mycophenolic Acid (DRUG).

Who is sponsoring clinical trial NCT00403416?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00403416's enrollment target sits among peer trials

215 243rd of 2000 higher than 1,757 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00403416, the US trial registry maintained by the National Library of Medicine. NCT00403416 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.