NCT00111085: CONSCIOUS-1

Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)

Completed Phase 2 Last updated 10 July 2018

What this trial tests

Phase 2 trial testing Clazosentan 1 mg/h in Aneurysmal Subarachnoid Hemorrhage in 413 participants. Completed in 30 March 2006.

Timeline

10 January 2005

Primary endpoint
30 March 2006

30 March 2006

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	prevention
Enrollment	413
Start date	10 January 2005
Primary completion	30 March 2006
Estimated completion	30 March 2006
Sites	16 locations across Canada, United States

Drugs / interventions tested

• Clazosentan 1 mg/h — full drug profile →
• Clazosentan 5 mg/h — full drug profile →
• Clazosentan 15 mg/h — full drug profile →
• Placebo

Conditions studied

• Aneurysmal Subarachnoid Hemorrhage — all drugs for Aneurysmal Subarachnoid Hemorrhage →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Aneurysmal Subarachnoid Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to measure how effective and safe three different doses of the drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endothelin Receptor Antagonists: Status Quo and Future Perspectives for Targeted Therapy.
   Enevoldsen FC, Sahana J, Wehland M, Grimm D, et al · · 2020 · cited 88× · PMID 32197449 · DOI 10.3390/jcm9030824
2. Dissociation of Early and Delayed Cerebral Infarction After Aneurysmal Subarachnoid Hemorrhage.
   Ayling OG, Ibrahim GM, Alotaibi NM, Gooderham PA, et al · · 2016 · cited 49× · PMID 27827324 · DOI 10.1161/strokeaha.116.014794
3. Anemia After Aneurysmal Subarachnoid Hemorrhage Is Associated With Poor Outcome and Death.
   Ayling OGS, Ibrahim GM, Alotaibi NM, Gooderham PA, et al · · 2018 · cited 45× · PMID 29946013 · DOI 10.1161/strokeaha.117.020260
4. Electrocardiographic changes predict angiographic vasospasm after aneurysmal subarachnoid hemorrhage.
   Ibrahim GM, Macdonald RL. · · 2012 · cited 33× · PMID 22678087 · DOI 10.1161/strokeaha.112.658153
5. Clinical, laboratory, and radiographic predictors of the occurrence of seizures following aneurysmal subarachnoid hemorrhage.
   Ibrahim GM, Fallah A, Macdonald RL. · · 2013 · cited 23× · PMID 23581590 · DOI 10.3171/2013.3.jns122097
6. Attributing hypodensities on CT to angiographic vasospasm is not sensitive and unreliable.
   Ibrahim GM, Weidauer S, Vatter H, Raabe A, et al · · 2012 · cited 20× · PMID 21998061 · DOI 10.1161/strokeaha.111.632745
7. Patient phenotypes associated with outcomes after aneurysmal subarachnoid hemorrhage: a principal component analysis.
   Ibrahim GM, Morgan BR, Macdonald RL. · · 2014 · cited 17× · PMID 24425125 · DOI 10.1161/strokeaha.113.003078
8. Acute kidney injury after aneurysmal subarachnoid hemorrhage and its effect on patient outcome: an exploratory analysis.
   Eagles ME, Powell MF, Ayling OGS, Tso MK, et al · · 2020 · cited 15× · PMID 31299650 · DOI 10.3171/2019.4.jns19103