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)

Cardiometabolics1 site in 1 country80 target enrollmentStarted: July 1, 2007Last updated: March 25, 2009

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor
Enrollment: 80
Locations: 1
Primary Endpoint: ICU Time

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 70 Years to — (Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:
•Age ≥ 70 to <80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

ICU Time

Time Frame: 30 to 45 days post-surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Cardiometabolics

Sponsor Class

Industry

Study Sites (1)

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