NCT01091870

Sildenafil for Prevention of Cerebral Vasospasm

Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the intracranial vessels lose their capability of self-control of dilations and contractions. Patients with subarachnoid hemorrhage without neurological deficits who underwent endovascular or surgical correction of the aneurysm can participate in this trial. They will be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from the third to the 14th day post bleeding. Today there is no proven clinical treatment for prevention of cerebral vasospasm.

Conditions

• Subarachnoid Hemorrhage
• Cerebral Vasospasm
• Rupture of Intracranial Aneurysm

Interventions

Type	Name	Description
DRUG	Placebo	Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.
DRUG	Sildenafil Citrate, 25 mg, 3 times a day.	Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
DRUG	Sildenafil Citrate 50 mg, 3 times a day	Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-12-01
• First posted: 2010-03-24
• Last updated: 2015-03-25

Locations

1 site across 1 country: Brazil