AtherosclerosisPhase 2NCT00715169
Double-Blind, Randomized, Placebo-Controlled Trial of MLN1202 on C-Reactive Protein Levels in Patients With Risk Factors for Cardiovascular Disease
A Phase 2 study testing MLN1202 in people with Atherosclerosis, run by Millennium Pharmaceuticals, Inc..
Trial summary
This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with risk factors for Atherosclerotic cardiovascular disease (ASCVD). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- MLN1202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Apr 2006
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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
This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with risk factors for Atherosclerotic cardiovascular disease (ASCVD). Patients with risk factors for ASCVD will be screened for inclusion and exclusion criteria including assessment of C-reactive protein. If the patient's CRP is greater than 3.0 mg/L on repeated measurements at least 2 weeks apart, the patient will be enrolled, stratified by screening CRP levels (≤5.0 mg/L and >5.0 mg/L), and randomized to receive 1 dose of either placebo or MLN1202. Safety will be assessed by vital signs, physical examination, clinical laboratories at baseline, and adverse event (AE) reporting from Day 1 to Day 113 of the trial.
- Conditions
- Atherosclerosis
- Being tested
- MLN1202, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN1202Drug
10 mg/kg dose of MLN1202 administered via IV infusion administered approximately 30 minutes to an hour
PlaceboOther
Placebo consist of 0.9% saline solution administered as a 10 mg/kg dose via IV infusion administered approximately 30 minutes to an hour
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: MLN1202 |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The change from baseline to Day 57 in CRP between patients treated withplacebo compared with MLN1202
Secondary outcomes (1)
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.
Measured: Baseline, Day 1 to Day 113 of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715169
- Sponsor's protocol ID
- MLN1202
- Status last verified
- Jul 2008
- First submitted
- 11 Jul 2008
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00715169
- Acronym / sponsor ID
- MLN1202
- Conditions
- Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2006 (actual)
- First posted
- 15 Jul 2008 (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.
This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with risk factors for Atherosclerotic cardiovascular disease (ASCVD). Patients with risk factors for ASCVD will be screened for inclusion and exclusion criteria including assessment of C-reactive protein. If the patient's CRP is greater than 3.0 mg/L on repeated measurements at least 2 weeks apart, the patient will be enrolled, stratified by screening CRP levels (≤5.0 mg/L and >5.0 mg/L), and randomized to receive 1 dose of either placebo or MLN1202. Safety will be assessed by vital signs, physical examination, clinical laboratories at baseline, and adverse event (AE) reporting from Day 1 to Day 113 of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MLN1202 |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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)
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 |
|---|---|---|
| MLN120210 mg/kg dose of MLN1202 administered via IV infusion administered approximately 30 minutes to an hour | Drug | 1 |
| PlaceboPlacebo consist of 0.9% saline solution administered as a 10 mg/kg dose via IV infusion administered approximately 30 minutes to an hour | Other | 2 |
Primary outcome
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
1 secondary outcome
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.
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 15 Jul 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLN1202 in people with Atherosclerosis, run by Millennium Pharmaceuticals, Inc..
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 7 inclusion and 16 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 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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). 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 15 Jul 2008.