Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
A Phase II, Double-Blind, Randomized, Exploratory, Placebo-Controlled Study of Efficacy, Safety, and Tolerability of MCC-135 Comparing QD vs BID Doses in Subjects With Congestive Heart Failure, NYHA Class II/III
2 other identifiers
interventional
204
1 country
53
Brief Summary
The purpose of this study is to determine the effect of two different doses of MCC-135, once daily (QD) or twice daily (BID), on the disease state and the quality of life in subjects 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
Started Aug 2002
Shorter than P25 for phase_2
53 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
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 20, 2002
CompletedFirst Posted
Study publicly available on registry
November 21, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFebruary 2, 2012
January 1, 2012
1 year
November 20, 2002
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the serum levels of brain natriuretic peptide
At Final Visit.
Secondary Outcomes (5)
Change from baseline in the Minnesota living with heart failure questionnaire score
At Final Visit.
Regular rate (heart rate) variability as measured by 24-hour Holter monitoring
At Final Visit.
Disease progression status measured by New York Heart Association class
At Final Visit.
Disease progression status measured by Global Clinical Status
At Final Visit.
Disease progression status measured by Clinical Composite
At Final Visit.
Study Arms (4)
MCC-135 50 mg BID
EXPERIMENTALMCC-135 100 mg QD
EXPERIMENTALMCC-135 200 mg QD
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Having a clinical diagnosis consistent with congestive heart failure, of at least 6 months duration and clinically stable for the last month.
- Has a left ventricular ejection fraction less than or equal to 40%.
- Has Plasma b-type (brain) natriuretic peptide levels greater than or equal to 200 pg/ml at screening.
- Meeting the following requirements for current concomitant medication:
- Must be using an angiotensin converting enzyme inhibitor or Angiotensin II receptor antagonists therapy for at least 1 month prior to the screening visit.
- If using beta-blockers, must have commenced treatment at least 4 months prior to the screening visit.
- All other cardiac medications must have been introduced at least one month prior to the screening visit.
You may not qualify if:
- Heart failure primarily due to:
- Obstructive valvular disease
- Malfunctioning artificial heart valve
- Congenital heart disease
- Pericardial disease
- Uncontrolled thyroid disease
- Amyloidosis
- Severe pulmonary disease
- Restrictive or obstructive cardiomyopathy
- Known active myocarditis
- Terminal heart failure or on waiting list for transplant.
- Atrio-ventricular block except for first-degree atrio-ventricular block.
- A history of or currently sustained ventricular tachycardia.
- Subjects with atrial fibrillation and/or requiring pacemakers (including bi-ventricular pacing).
- Presence of pulmonary embolism.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (53)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
University of Arizona Medical Center
Tucson, Arizona, 85724, United States
Capitol Intervention Cardiology
Carmichael, California, 95608, United States
San Diego Cardiovascular
Encinitas, California, 92024, United States
LAC & USC Medical Center
Los Angeles, California, 90033, United States
ARI Clinical Trials, Inc Arrhythmia Research & Cardiology Health Center
Redondo Beach, California, 90027, United States
Clinical Trials Research
Roseville, California, 95661, United States
Sacramento Heart & Vascular Medical Associates
Sacramento, California, 95825, United States
University of California San Diego
San Diego, California, 92103, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Cardiology Consultants PA
Daytona Beach, Florida, 32114, United States
Cardiology Associates of Fort Lauderdale
Fort Lauderdale, Florida, 33308, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
Southern Clinical Research & Management
Augusta, Georgia, 30904, United States
Medical Group of Fort Wayne, PC
Fort Wayne, Indiana, 46804, United States
Medical Center Cardiologist
Louisville, Kentucky, 40202, United States
Louisville Cardiology Medical Group, PSC
Louisville, Kentucky, 40207, United States
Louisiana Heart Center
Chalmette, Louisiana, 70043, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Cardiac Center of Louisiana, LLC
Shreveport, Louisiana, 71103, United States
Cardiology Associates, PC
Annapolis, Maryland, 21114, United States
University of Maryland Hospital
Baltimore, Maryland, 21201, United States
Cardiovascular Consultants, PA
Takoma Park, Maryland, 20901, United States
University of Massachusettes
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68510, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Unknown Facility
Millburn, New Jersey, 07041, United States
South Jersey Heart Group
Sewell, New Jersey, 08080, United States
Buffalo General Hospital
Buffalo, New York, 14203, United States
Heart Care Center East
Fayetteville, New York, 13066, United States
Hudson Valley Clinical Research
Kingston, New York, 12401, United States
Saint Vincent Catholic Medical Center
New York, New York, 10011, United States
University of Rochester
Rochester, New York, 14618, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Sterling Research Group
Cincinnati, Ohio, 45219, United States
North Ohio Research, Ltd.
Lorain, Ohio, 44053, United States
City Cardiology Associates, Inc.
Stow, Ohio, 44224, United States
Chestnut Hill Cardiology, Ltd.
Flourtown, Pennsylvania, 19031, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Carolina Research Associates
Columbia, South Carolina, 29206, United States
The Stern Cardiovascular Center
Memphis, Tennessee, 38120, United States
Cardiovascular Research Institute of Dallas Medical Center - Cardiologist Research Foundation
Dallas, Texas, 75231, United States
Med-Tech Research
Houston, Texas, 77055, United States
Unknown Facility
Nassau Bay, Texas, 77058, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Cardiovascular Associates, Ltd.
Chesapeake, Virginia, 23320, United States
Wisconsin Center for Clinical Research, LLC
Elkhorn, Wisconsin, 53121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Clinical Science Strategy
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2002
First Posted
November 21, 2002
Study Start
August 1, 2002
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
February 2, 2012
Record last verified: 2012-01