Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
Public ClinicalTrials.gov record NCT01128335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients
Study identification
- NCT ID
- NCT01128335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- MMF(1000mg bid) + tacrolimus + standard of care medications Drug
- sotrastaurin (200mg bid) + tacrolimus + standard of care medications Drug
- sotrastaurin (300 mg bid) + tacrolimus + standard of care medications Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2010
- Primary completion
- Jun 30, 2012
- Completion
- Jun 30, 2012
- Last update posted
- Dec 21, 2020
2010 – 2012
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90095 | — |
| Novartis Investigative Site | San Francisco | California | 94143 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202-2689 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | — |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | — |
| Novartis Investigative Site | Dallas | Texas | 75246 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01128335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2020 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01128335 live on ClinicalTrials.gov.