CDFS-JPSK

A multi-center, international, double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in adult patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222837

Enrollment

168

Registered

2015-04-28

Start date

2009-06-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal subarachnoid hemorrhage (aSAH)

Interventions

investigational material(s) Generic name etc : ACT-108475 INN of investigational material : clazosentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients treated by surgical clipping WFNS GradeI - IV Fisher group 3

Exclusion criteria

Exclusion criteria: Presence of cerebral vasospasm seen prior to the clipping procedure etc.

Design outcomes

Primary

Measure	Time frame
pharmacodynamics The occurrence of moderate or severe cerebral vasospasm after aSAH. DSA	—

Secondary

Measure	Time frame
efficacy The occurrence of new or/and worsened cerebral infarct(s) associated with cerebral vasospasm after aSAH. CT	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026