Trial | NCT00500929  Report issue

Title

A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
Mini-Metrxics: A Single-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Clinical Trial of CMI X-11S in Higher Risk Geriatric Patients Undergoing Open-Heart Surgical Procedures (OHSP)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.
Study Started
Jul 31
2007
Primary Completion
Apr 30
2008
Study Completion
May 31
2008
Last Update
Mar 25
2009
Estimate

Drug CMI X-11S

Criteria 

Inclusion Criteria:

Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:

Either:

Age ≥ 70 to <80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR
Age ≥ 80
No Results Posted