NCT02024373

Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

Detailed description

Study design: Multi-center, randomized, double-blind, placebo parallel controlled Subjects: Patients with chronic subdural hematoma (CSDH) Sample size: 200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
DRUG	Atorvastatin	20 mg (every evening orally) for 8 weeks
DRUG	placebo	20 mg (every evening orally) for 8 weeks

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-04-01
• Completion: 2016-09-01
• First posted: 2013-12-31
• Last updated: 2016-10-25

Locations

31 sites across 1 country: China