Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Efficacy and Safety Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
1 other identifier
interventional
170
1 country
25
Brief Summary
The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedJune 28, 2011
November 1, 2010
8 months
January 22, 2010
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion.
8 weeks
Secondary Outcomes (1)
To assess the effects of lixivaptan treatment in CHF patients with volume expansion.
8 weeks
Study Arms (2)
Lixivaptan
EXPERIMENTALCapsule, 100mg Lixivaptan or matching placebo once daily.
Placebo
PLACEBO COMPARATORPatients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.
Interventions
Capsule. Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. One hundred (100) patients will be randomized to receive lixivaptan 100 mg once daily (QD) for 8 weeks. Fifty (50) placebo patients will receive matching oral placebo for 8 weeks.
Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.
Eligibility Criteria
You may qualify if:
- Ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
- Men and women aged 18 years or older.
- History of chronic CHF defined as requiring standard HF treatment (including diuretics) for a minimum of 30 days.
- Documented LVEF by any method within 12 months prior to screening.
- Dyspnea
- Pulmonary congestion (rales)
- Peripheral edema
- Increased jugular venous pressure and/or hepatic congestion with ascites
- Chest x-ray consistent with CHF
- Plasma brain natriuretic peptide (BNP) ≥150 pg/mL or N-terminal prohormone brain natriuretic peptide (NT pro-BNP) ≥450 pg/mL
You may not qualify if:
- Women who are pregnant (positive pregnancy test), breastfeeding, or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form (ICF).
- Sustained (three blood pressure measurements over 1 hour) systolic blood pressure \<90 mmHg at Screening or Day 0.
- ST segment elevation myocardial infarction or stroke within 30 days prior to Screening.
- Hemodynamically destabilizing cardiac arrhythmia within 30 days prior to Day 0.
- Clinically significant valvular disease.
- Known clinically significant obstructive, restrictive, or hypertrophic cardiomyopathy.
- Cardiac surgery or percutaneous coronary intervention within 30 days prior to Day 0.
- Major surgical procedure within 7 days prior to Day 0.
- Likely to undergo cardiac transplantation, left ventricular assist device (LVAD) or other device implantation, or other cardiac surgery within 3 months after Screening.
- Placement of implantable cardioverter defibrillator or cardiac resynchronization therapy device within 60 days prior to Day 0.
- CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
- Presence of any clinically significant (as determined by the Investigator) endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, oncologic, and/or other major disease that might interfere with safe and compliant participation in this study.
- Screening laboratory findings as follows:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal
- Total bilirubin \>2.0 mg/dL
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioKine Inc.lead
- Cardiokine Biopharma, LLCcollaborator
Study Sites (25)
Mobile Heart Specialists, PC
Mobile, Alabama, 36608, United States
Phoenix Clinical
Phoenix, Arizona, 85029, United States
Nea Clinic
Jonesboro, Arkansas, 72401, United States
Capitol Interventional Cardiology
Carmichael, California, 95608, United States
Merced Heart Associates
Merced, California, 95340, United States
Orange County Heart Institute and Research Center
Orange, California, 92868, United States
Innovative Research of West Florida, Inc
Clearwater, Florida, 33756, United States
Edgewater Medical Research Inc
Edgewater, Florida, 32141, United States
Foundation/Research/Cardiovascular Specialists Lower Keys
Key West, Florida, 33040, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, 33952, United States
Tampa Clinical Research
Tampa, Florida, 33624, United States
Executive Health and Research Associates, Inc
Atlanta, Georgia, 30342, United States
In-Quest Medical Research, LLC
Duluth, Georgia, 30096, United States
Fox Valley Clinical Research Center
Aurora, Illinois, 60504, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Primary Care Cardiology Research, Inc
Ayer, Massachusetts, 01432, United States
Horizon Research
St Louis, Missouri, 63141, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
Raleigh Cardiology
Raleigh, North Carolina, 27610, United States
Clinical Research Limited
Canton, Ohio, 44718, United States
Dayton Heart Center
Dayton, Ohio, 45414, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231, United States
East Texas Cardiology
Houston, Texas, 77002, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
National Clinical Research - Richmond
Richmond, Virginia, 23294, United States
Related Publications (1)
Ghali JK, Orlandi C, Abraham WT; CK-LX2401 Study Investigators. The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study. Eur J Heart Fail. 2012 Jun;14(6):642-51. doi: 10.1093/eurjhf/hfs051. Epub 2012 Apr 17.
PMID: 22510424DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 26, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2010
Last Updated
June 28, 2011
Record last verified: 2010-11