Safety and Tolerability of GV150526 in Patients With Acute Stroke

Completed

Phase 2 Results

Summary of Purpose

To assess the safety, tolerability, and pharmacokinetics of loading and maintenance infusions of GV150526 in patients with acute stroke.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 19 July 2001.

Unavailable Unavailable Unavailable Unavailable Unavailable Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Basics

Interventions

Sponsors

  • Glaxo Wellcome, Research Triangle, NC

Trial Design

Randomized, placebo-controlled, parallel-group, ascending-dose study conducted in 2 phases. In part A of the study, loading doses of 50, 100, 200, 400, or 800 mg were administered. In part B, the maximum loading dose from part A was followed by maintenance infusions (5 infusions at 12-hour intervals), aiming to maintain neuroprotective levels. The trial included 66 patients.

Contacts

  • Dr A.G. Dyker, University Department of Medicine and Therapeutics, Western Infirmary, Glasgow G11 6NT, Scotland.

    ad47q@clinmed.gla.ac.uk