Status:
COMPLETED
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
Lead Sponsor:
Trevena Inc.
Conditions:
Heart Failure
Kidney Disease
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
Eligibility Criteria
Inclusion
- Written Informed Consent
- Heart Failure
- Mild to moderate renal dysfunction
- Age 18- \<75
- Males and females (non-childbearing potential)
Exclusion
- Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests
- Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator
- Allergy or clinically-significant intolerance to ARBs or ACE inhibitors
- Clinical signs or symptoms of acute decompensated heart failure
- Pregnant or lactating
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01444872
Start Date
August 1 2011
End Date
June 1 2012
Last Update
August 27 2012
Active Locations (4)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
3
Duke Clinical Research Unit
Durham, North Carolina, United States, 27705
4
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920