Trial record 1 of 1 for:    NCT01187836
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Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.
ClinicalTrials.gov Identifier:
NCT01187836
First received: August 20, 2010
Last updated: April 13, 2012
Last verified: April 2012

August 20, 2010
April 13, 2012
December 2010
March 2012   (final data collection date for primary outcome measure)
  • Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion ] [ Designated as safety issue: No ]
    The effect of TRV120027 on pulmonary capillary wedge pressure will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.
  • Safety and Tolerability [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30) ] [ Designated as safety issue: No ]
    Safety and tolerability will be assessed qualitatively by evaluating adverse events, clinical laboratories, ECGs, cardiac telemetry and vital signs at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. Follow-up assessments for adverse events at Day 7 and Day 30 will be conducted.
Same as current
Complete list of historical versions of study NCT01187836 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of TRV120027 [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion ] [ Designated as safety issue: No ]
    PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods.
  • Additional Hemodynamics [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion ] [ Designated as safety issue: No ]
    Additional hemodynamic variables (for example, right atrial pressure, pulmonary arterial pressure and cardiac output) will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.
  • Laboratory Evaluations [ Time Frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7) ] [ Designated as safety issue: No ]
    Biomarkers of renal function and neurohormonal activation will be assessed at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion, and again at follow-up Day 7.
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
A Randomized, Double-Blind, Placebo-Controlled, Adaptive, Ascending Dose-Titration Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Invasive Hemodynamics of TRV120027 in Patients With Stable Heart Failure

In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of TRV120027. The results of this study will help choose the proper range of TRV120027 doses to use in future research studies involving patients with acute decompensated heart failure.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: TRV120027
    Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.
  • Drug: Placebo
    Placebo administered for 14 hours.
  • Experimental: TRV120027
    Intervention: Drug: TRV120027
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of congestive heart failure made at least 3 months prior to screening
  • NYHA Class III or IV heart failure, ejection fraction </= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated.
  • Baseline mean PCWP >/= 20 mmHg
  • Systolic blood pressure at screening must be >/= 100 mmHg. Heart rate at screening must be </= 90 bpm.

Exclusion Criteria:

  • Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests.
  • Significant valve disease
  • Current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (ACS) or coronary revascularization in the past 3 months.
  • Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Poland
 
NCT01187836
CP120027.2001, 2010-020376-37
Not Provided
Trevena Inc.
Trevena Inc.
Not Provided
Study Director: David G Soergel, M.D. Trevena Inc.
Trevena Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP