Trials / Completed
CompletedNCT01418729
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma
Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Hospital Donostia · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pravastatin | Treatment: Patients will be randomized in two groups, A and B: * Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h. * Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h. |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2015-12-01
- Completion
- 2017-06-01
- First posted
- 2011-08-17
- Last updated
- 2017-09-20
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01418729. Inclusion in this directory is not an endorsement.