Pilot Study of COR-1 in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corimmun GmbH
ClinicalTrials.gov Identifier:
NCT01391507
First received: July 4, 2011
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: August 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cardiomyopathy, Dilated
Interventions: Drug: 0.9 % sodium chloride
Drug: COR-1
Drug: Standard therapy for heart failure

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
COR-1 20 Milligram (mg) COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
COR-1 80 mg COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
COR-1 160 mg COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

Participant Flow:   Overall Study
    Placebo     COR-1 20 Milligram (mg)     COR-1 80 mg     COR-1 160 mg  
STARTED     10     8     6     12  
COMPLETED     6     4     2     5  
NOT COMPLETED     4     4     4     7  
Death                 0                 0                 0                 1  
Adverse Event                 1                 1                 2                 2  
Withdrawal by Subject                 1                 2                 1                 1  
Lack of Efficacy                 0                 0                 0                 1  
Protocol Violation                 2                 1                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment.

Reporting Groups
  Description
Placebo Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
COR-1 20 Milligram (mg) COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
COR-1 80 mg COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
COR-1 160 mg COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
Total Total of all reporting groups

Baseline Measures
    Placebo     COR-1 20 Milligram (mg)     COR-1 80 mg     COR-1 160 mg     Total  
Number of Participants  
[units: participants]
  10     8     6     12     36  
Age  
[units: years]
Mean ± Standard Deviation
  59.4  ± 9.61     57.5  ± 10.92     62  ± 13.59     59.8  ± 11.88     59.6  ± 10.97  
Gender  
[units: participants]
         
Female     3     2     1     2     8  
Male     7     6     5     10     28  
Region of Enrollment  
[units: participants]
         
Germany     10     8     6     12     36  



  Outcome Measures
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1.  Primary:   Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6   [ Time Frame: Baseline and Month 6 ]

2.  Secondary:   Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9   [ Time Frame: Baseline and Month 9 ]

3.  Secondary:   Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6   [ Time Frame: Baseline and Month 6 ]

4.  Secondary:   Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6   [ Time Frame: Baseline and Month 6 ]

5.  Secondary:   Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6   [ Time Frame: Baseline and Month 6 ]

6.  Secondary:   Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6   [ Time Frame: Baseline and Month 6 ]

7.  Secondary:   Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression   [ Time Frame: Baseline and Month 6 ]

8.  Secondary:   Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6   [ Time Frame: Baseline and Month 6 ]

9.  Secondary:   Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6   [ Time Frame: Baseline and Month 6 ]

10.  Secondary:   Number of Participants With Holter Electrocardiography (ECG) Parameters   [ Time Frame: Baseline and Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the decision to amend protocol to a pilot study coupled with the high study agent discontinuation rate, safety or efficacy of JNJ-54452840 could not be concluded due to the insufficient sample size and drug exposure to investigational agent.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director Biostatistics
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications:


Responsible Party: Corimmun GmbH
ClinicalTrials.gov Identifier: NCT01391507     History of Changes
Other Study ID Numbers: CR100913, 2010-022579-68, COR-1/02
Study First Received: July 4, 2011
Results First Received: August 11, 2014
Last Updated: August 11, 2014
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices