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Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

NCT01336959 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2020-11-06

Study results available
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Summary

This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.

Conditions

Interventions

DRUG

BCT197 Part A

open label single dose administration of 10mg BCT197, 2 hours prior to surgery

DRUG

Placebo

Single dose matching placebo administered 2 prior to surgery

DRUG

BCT197 Part B

BCT197 50mg single dose administered 2 hours prior to surgery

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Mereo BioPharma

    lead INDUSTRY

Principal Investigators

  • Jacqueline Parkin, PhD FRCP · Mereo BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • Israel
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336959 on ClinicalTrials.gov