- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715169
Double-Blind, Randomized, Placebo-Controlled Trial of MLN1202 on C-Reactive Protein Levels in Patients With Risk Factors for Cardiovascular Disease
Phase 2 A, Double-Blind, Randomized, Placebo-Controlled Trial Measuring the Effects of MLN1202 on C-Reactive Protein Levels in Patients With Risk Factors for Cardiovascular Disease
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female age 35 years or older
- Willing and able to comply with the protocol for the duration of the study
- Willing to use adequate double-barrier contraceptive methods for the duration of the study
- Presence of 2 or more of the following risk factors for ASCVD:
Age of 45 years (male) or 55 years (female) or greater History of or current cigarette smoking of ≥20 pack years History of hypertension Body mass index (BMI) defined as weight (kg) divided by height (in m2) ≥30 History of hypercholesterolemia defined as fasting low-density lipoprotein >130 mg/dL History of high-density lipoprotein levels of 40 mg/dL or less Diabetes mellitus Family history of a definable ASCVD event (myocardial infarction or intervention)in a first-degree relative prior to the age of 55 (male) or 65 (female)
- Patients with hypercholesterolemia may be on stable doses of lipid-lowering agents with no change in regimen/dose within 60 days prior to randomization
- Have high-sensitivity C-reactive protein (from peripheral blood) levels >3.0 mg/L on more than 1 test date separated by at least 2 weeks in the last 12 months; the most recent hsCRP must be measured during Screening within 14 days of randomization
Exclusion Criteria:
- History of stroke History of acute coronary syndrome (ACS) including unstable angina, acute myocardial infarction (both ST segment elevation and non-ST segment elevation) or stable angina
- Evidence of coronary artery disease as determined by either prior history of CAD-related event (stable angina, unstable angina, MI) or evidence on diagnostic procedure (exercise stress test, echocardiogram, stress test, radionucleotide stress test, others) that in the opinion of the investigator is consistent with CAD
- Diagnosis of congestive heart failure or clinical evidence suggesting CHF including history of orthopnea, exertional dyspnea, pedal edema, pulmonary rales, hepatosplenomegaly, cardiomegaly, and a prediastolic (S3) gallop
- Uncontrolled hypertension with a blood pressure >140/90 at Screening
- Concurrent chronic inflammatory illness (eg, inflammatory bowel disease, rheumatoid arthritis, chronic obstructive pulmonary disease, asthma, systemic lupus erythematosus) or concurrent chronic infectious illness (eg, human immunodeficiency virus, tuberculosis, hepatitis, osteomyelitis)
- Concurrent use of anti-inflammatory or disease-modifying agents (eg, methotrexate,azathioprine, oral corticosteroids). Past use (>3 months) of these anti-inflammatory ordisease modifying agents is acceptable. Aspirin, clopidogrel, and nonsteroidal antiinflammatory drugs are acceptable
- History of cancer with the exception of cervical carcinoma-in-situ or basal cell carcinoma of the skin within the last 5 years
- History of receiving live attenuated vaccine within last 60 days prior to randomization
- Use of an investigational product in the last 60 days prior to randomization
- History of illicit drug use or alcohol abuse in the last year
- History of or planned percutaneous coronary intervention, such as angioplasty or coronary stent placement, or coronary artery bypass graft or other vascular surgery planned within study duration
- Chest X-ray within 6 months prior to study entry with clinically significant findings, in the opinion of the investigator Screening electrocardiogram obtained once during Screening Days -14 to -1 with clinically significant findings, in the opinion of the investigator
- Renal function reflected by a serum creatinine ≥1.5 times the upper limit of normal
- Hepatic function reflected by elevated liver function tests (eg, aspartate aminotransferase, alanine aminotransferase or total bilirubin) ≥2 times the ULN
- If female, positive results on a serum pregnancy test or breastfeeding
- Any other reason in the opinion of the investigator that a subject should not be enrolled in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Placebo consist of 0.9% saline solution administered as a 10 mg/kg dose via IV infusion administered approximately 30 minutes to an hour
|
Active Comparator: 1
|
10 mg/kg dose of MLN1202 administered via IV infusion administered approximately 30 minutes to an hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the effect of C-C Chemokine Receptor-2 (CCR2) blockade in reducing Creactive protein (CRP) levels in patients with risk factors for atherosclerotic cardiovascular disease (ASCVD) and a baseline elevation of CRP
Time Frame: The change from baseline to Day 57 in CRP between patients treated withplacebo compared with MLN1202
|
The change from baseline to Day 57 in CRP between patients treated withplacebo compared with MLN1202
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Elevation of Creactive protein (CRP) number of days from baseline until the first 1.0 mg/L decrease in CRP levels and changes from baseline to other study visits.
Time Frame: Baseline, Day 1 to Day 113 of the trial.
|
Baseline, Day 1 to Day 113 of the trial.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MLN1202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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