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NCT01064791 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 298
- Enrollment target
NCT01064791 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 298 participants.
The verdict
NCT01064791, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 298 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
Interventions
- DRUG sotrastaurin (Dose 1) + tacrolimus + standard of care medications
- DRUG sotrastaurin (Dose 2) + tacrolimus + standard of care medications
- DRUG sotrastaurin (Dose 3) + tacrolimus + standard of care medications
- DRUG mycophenolic acid + tacrolimus + standard of care medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01064791
The ClinicalTrials.gov registry entry for NCT01064791 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 298 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 sotrastaurin (Dose 1) + tacrolimus + standard of care medications is the first listed.
NCT01064791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01064791 about?
NCT01064791 is a clinical study titled "Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients". This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
What is the current status of trial NCT01064791?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 298 participants. The study started on 2009-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01064791?
The interventions under investigation include: sotrastaurin (Dose 1) + tacrolimus + standard of care medications (DRUG), sotrastaurin (Dose 2) + tacrolimus + standard of care medications (DRUG), sotrastaurin (Dose 3) + tacrolimus + standard of care medications (DRUG), mycophenolic acid + tacrolimus + standard of care medications (DRUG).
Who is sponsoring clinical trial NCT01064791?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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