Trial Outcomes & Findings for Simvastatin For Intracerebral Hemorrhage Study (NCT NCT00718328)

NCT ID: NCT00718328

Last Updated: 2017-10-09

Results Overview

Solitary patient lost to follow up (out of state)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Days 7 and 14
• Results posted on: 2017-10-09

Participant Flow

Recruitment period October 2008- June 2009, Inpatient (ICU)

No issues prior to assignment

Participant milestones

Measure	Simvastatin Group Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.	Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Simvastatin Group Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.	Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Simvastatin For Intracerebral Hemorrhage Study

Baseline characteristics by cohort

Measure	Simvastatin Group n=1 Participants Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.	Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants	—	62 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 7 and 14

Solitary patient lost to follow up (out of state)

Outcome measures

Measure	Simvastatin Group n=1 Participants Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.	Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
Perihematomal Edema	NA Relative perihematomal edema Standard Deviation NA Patient lost to follow up	—

Adverse Events

Simvastatin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Neeraj Naval

Johns Hopkins University SOM (former employer during the study)

Phone: 9042026290

Email: neerajnaval@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place