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NCT00400400 · ClinicalTrials.gov registry record · Phase 4

Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

A Phase 4 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
400
Enrollment target

NCT00400400 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 400 participants.

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The verdict

NCT00400400, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
400 participants
Enrollment target

Study Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Interventions

  • DRUG Mycophenolate mofetil
  • DRUG Enteric-coated mycophenolate sodium (EC-MPS)
  • DRUG Placebo to mycophenolate sodium
  • DRUG Placebo to mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2006-10
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00400400

The ClinicalTrials.gov registry entry for NCT00400400 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Mycophenolate mofetil is the first listed.

NCT00400400 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00400400 about?

NCT00400400 is a clinical study titled "Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance". Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of ...

What is the current status of trial NCT00400400?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2006-10.

What interventions are being tested in trial NCT00400400?

The interventions under investigation include: Mycophenolate mofetil (DRUG), Enteric-coated mycophenolate sodium (EC-MPS) (DRUG), Placebo to mycophenolate sodium (DRUG), Placebo to mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00400400?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.