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 (ESTAHEP-2010)

NCT01418729 Phase 2 COMPLETED

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.

Details

Lead sponsor	Hospital Donostia
Phase	Phase 2
Status	COMPLETED
Enrolment	216
Start date	2011-09
Completion	2017-06

Conditions

• Advanced Hepatocarcinoma

Interventions

• Pravastatin

Primary outcomes

• Overall survival — 18 months
  To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Countries

Spain