Congestive Heart FailurePhase 2NCT00050076
Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
A Phase 2 study testing MCC-135 in people with Congestive Heart Failure, run by Takeda at 53 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- MCC-135
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 53 sitesUnited States
- Study dates
- Aug 2002to Aug 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Heart failure primarily due to:
- Obstructive valvular disease
- Malfunctioning artificial heart valve
- Congenital heart disease
- Pericardial disease
- Uncontrolled thyroid disease
Show all 35Show fewer
- 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.
- Acute myocardial infarction, unstable angina, coronary revascularization or major surgery during the last 6 weeks prior to screening.
- Episode of syncope or cardiac arrest during the last 6 weeks prior to screening.
- Requiring treatment with the following therapies:
- Anti-arrhythmics (Amiodarone/beta-blockers are permitted)
- Calcium sensitizers
- Catecholamines
- Phosphodiesterase inhibitors
- Is currently participating in another investigational study or who have participated in an investigational study (including MCC-135) during the 2 months prior to the screening visit
- Has a history of drug or alcohol abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders-4th edition criteria, within the past two years.
- Has significant, moderate-severe renal dysfunction or disease, confirmed by serum creatinine of greater than 2mg/dl (180 micromol/L).
- Serum potassium levels at entry confirmed below 3.5mmol/L.
- Known severe symptomatic primary pulmonary disease in the last 5 years e.g. asthma, chronic obstructive pulmonary disease.
- Concurrent severe disease (including significant hepatic, metabolic or other systemic disease) or any medical condition that, in the opinion of the investigator, would compromise the subject's safety or their successful participation in the study.
- History of multiple drug allergies or with a known allergy to the study drug or any medicine chemically related to the study drug.
- Individuals who are morbidly obese.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Anti-arrhythmics (Amiodarone/beta-blockers are permitted)
- Calcium sensitizers
- Catecholamines
- Phosphodiesterase inhibitors
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
University of Michigan
Ann Arbor, Michigan, 48109
Cardiology Associates, PC
Annapolis, Maryland, 21114
Southern Clinical Research & Management
Augusta, Georgia, 30904
University of Maryland Hospital
Baltimore, Maryland, 21201
Buffalo General Hospital
Buffalo, New York, 14203
Capitol Intervention Cardiology
Carmichael, California, 95608
Louisiana Heart Center
Chalmette, Louisiana, 70043
Medical University of South Carolina
Charleston, South Carolina, 29425
Cardiovascular Associates, Ltd.
Chesapeake, Virginia, 23320
Sterling Research Group
Cincinnati, Ohio, 45219
Carolina Research Associates
Columbia, South Carolina, 29206
Cardiovascular Research Institute of Dallas Medical Center - Cardiologist Research Foundation
Dallas, Texas, 75231
Cardiology Consultants PA
Daytona Beach, Florida, 32114
Henry Ford Health System
Detroit, Michigan, 48202
Henry Ford Hospital
Detroit, Michigan, 48202
Wisconsin Center for Clinical Research, LLC
Elkhorn, Wisconsin, 53121
San Diego Cardiovascular
Encinitas, California, 92024
Heart Care Center East
Fayetteville, New York, 13066
Chestnut Hill Cardiology, Ltd.
Flourtown, Pennsylvania, 19031
Cardiology Associates of Fort Lauderdale
Fort Lauderdale, Florida, 33308
Medical Group of Fort Wayne, PC
Fort Wayne, Indiana, 46804
Med-Tech Research
Houston, Texas, 77055
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Hudson Valley Clinical Research
Kingston, New York, 12401
Bryan LGH Heart Institute
Lincoln, Nebraska, 68510
North Ohio Research, Ltd.
Lorain, Ohio, 44053
LAC & USC Medical Center
Los Angeles, California, 90033
Medical Center Cardiologist
Louisville, Kentucky, 40202
Louisville Cardiology Medical Group, PSC
Louisville, Kentucky, 40207
The Stern Cardiovascular Center
Memphis, Tennessee, 38120
Study site
Millburn, New Jersey, 07041
Study site
Nassau Bay, Texas, 77058
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
Ochsner Clinic
New Orleans, Louisiana, 70121
Saint Vincent Catholic Medical Center
New York, New York, 10011
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Maricopa Medical Center
Phoenix, Arizona, 85008
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
ARI Clinical Trials, Inc Arrhythmia Research & Cardiology Health Center
Redondo Beach, California, 90027
University of Rochester
Rochester, New York, 14618
Clinical Trials Research
Roseville, California, 95661
Sacramento Heart & Vascular Medical Associates
Sacramento, California, 95825
University of California San Diego
San Diego, California, 92103
Apex Research Institute
Santa Ana, California, 92705
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
South Jersey Heart Group
Sewell, New Jersey, 08080
Cardiac Center of Louisiana, LLC
Shreveport, Louisiana, 71103
City Cardiology Associates, Inc.
Stow, Ohio, 44224
Cardiovascular Consultants, PA
Takoma Park, Maryland, 20901
Albert Einstein College of Medicine
The Bronx, New York, 10461
University of Arizona Medical Center
Tucson, Arizona, 85724
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
University of Massachusettes
Worcester, Massachusetts, 01655
About this study
Official title: 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
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.
Read the detailed description
In recent years the usefulness of angiotensin converting enzyme inhibitors and vasodilators as well as beta-blockers has been realized in the treatment of heart failure. Multi-center studies clinical trials have shown some benefit of angiotensin converting enzyme inhibitors on the morbidity and mortality of heart failure subjects, and physicians are also prescribing angiotensin converting enzyme inhibitors for the initial treatment of subjects with left ventricular dysfunction. Some subjects do not respond to angiotensin converting enzyme inhibitors and intolerance to these compounds has also been observed. Despite the significant reduction in mortality observed in limited controlled studies, the 5-year mortality of subjects with congestive heart failure continues to be high, indicating that there is a significant therapeutic gap in the treatment of this disease.
MCC-135 is being studied to assess its usefulness as a supplement or replacement to current treatment and to provide subjects with specific and predictable therapy that will reverse the remodeling of the diseased heart and markedly improve the subject's survival. The current study is an exploratory clinical trial to determine the efficacy of two doses and two dose regimens of MCC-135 when compared to placebo by evaluating improvement in the subject's plasma b-type (brain) natriuretic peptide levels, regular rate (heart rate) variability and clinical signs and symptoms.
- Conditions
- Congestive Heart Failure
- Being tested
- MCC-135, Placebo
- Keywords
- Congestive Heart Failure, Cardiac Failure, Heart Decompensation, Drug Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCC-135Drug
MCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks
MCC-135Drug
MCC-135 100 mg, tablets, orally, once daily for up to 12 weeks
MCC-135Drug
MCC-135 200 mg, tablets, orally, once daily for up to 12 weeks
PlaceboDrug
MCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| MCC-135 50 mg BID | Experimental | Not described Receives: Drug: MCC-135 |
| MCC-135 100 mg QD | Experimental | Not described Receives: Drug: MCC-135 |
| MCC-135 200 mg QD | Experimental | Not described Receives: Drug: MCC-135 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the serum levels of brain natriuretic peptide
Measured: At Final Visit.
Secondary outcomes (5)
Change from baseline in the Minnesota living with heart failure questionnaire score
Measured: At Final Visit.
Regular rate (heart rate) variability as measured by 24-hour Holter monitoring
Measured: At Final Visit.
Disease progression status measured by New York Heart Association class
Measured: At Final Visit.
Disease progression status measured by Global Clinical Status
Measured: At Final Visit.
Disease progression status measured by Clinical Composite
Measured: At Final Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2002 (estimated)
- Study startAug 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science Strategy, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050076
- Sponsor's protocol ID
- 01-02-TL-MCC135-001
- Other IDs
- U1111-1127-6077
- Status last verified
- Jan 2012
- First submitted
- 20 Nov 2002
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00050076
- Acronym / sponsor ID
- 01-02-TL-MCC135-001
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Cardiac Failure, Heart Decompensation, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 21 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years the usefulness of angiotensin converting enzyme inhibitors and vasodilators as well as beta-blockers has been realized in the treatment of heart failure. Multi-center studies clinical trials have shown some benefit of angiotensin converting enzyme inhibitors on the morbidity and mortality of heart failure subjects, and physicians are also prescribing angiotensin converting enzyme inhibitors for the initial treatment of subjects with left ventricular dysfunction. Some subjects do not respond to angiotensin converting enzyme inhibitors and intolerance to these compounds has also been observed. Despite the significant reduction in mortality observed in limited controlled studies, the 5-year mortality of subjects with congestive heart failure continues to be high, indicating that there is a significant therapeutic gap in the treatment of this disease.
MCC-135 is being studied to assess its usefulness as a supplement or replacement to current treatment and to provide subjects with specific and predictable therapy that will reverse the remodeling of the diseased heart and markedly improve the subject's survival. The current study is an exploratory clinical trial to determine the efficacy of two doses and two dose regimens of MCC-135 when compared to placebo by evaluating improvement in the subject's plasma b-type (brain) natriuretic peptide levels, regular rate (heart rate) variability and clinical signs and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MCC-135 50 mg BID | Experimental | Drug: MCC-135 |
| MCC-135 100 mg QD | Experimental | Drug: MCC-135 |
| MCC-135 200 mg QD | Experimental | Drug: MCC-135 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (35 listed)
- Heart failure primarily due to:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCC-135MCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks | Drug | MCC-135 50 mg BID |
| MCC-135MCC-135 100 mg, tablets, orally, once daily for up to 12 weeks | Drug | MCC-135 100 mg QD |
| MCC-135MCC-135 200 mg, tablets, orally, once daily for up to 12 weeks | Drug | MCC-135 200 mg QD |
| PlaceboMCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks | Drug | Placebo |
Primary outcome
Change from baseline in the serum levels of brain natriuretic peptide
Time frame: At Final Visit.
5 secondary outcomes
Change from baseline in the Minnesota living with heart failure questionnaire score
Time frame: At Final Visit.
Regular rate (heart rate) variability as measured by 24-hour Holter monitoring
Time frame: At Final Visit.
Disease progression status measured by New York Heart Association class
Time frame: At Final Visit.
Disease progression status measured by Global Clinical Status
Time frame: At Final Visit.
Disease progression status measured by Clinical Composite
Time frame: At Final Visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VP Clinical Science Strategy study director
Takeda
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MCC-135 in people with Congestive Heart Failure, run by Takeda at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the serum levels of brain natriuretic peptide (time frame: At Final Visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.