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Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain

NCT03585270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2024-01-10

Study results available
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Summary

This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Clazosentan

Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.

DRUG

Placebo

Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-03
Primary Completion
2022-06-13
Completion
2022-11-18
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585270 on ClinicalTrials.gov