AnemiaPhase 4NCT01394991
A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia
A Phase 4 study testing Epoetin alfa 450 IU/kg once a week, Epoetin alfa 150 IU/kg 3 times a week and Epoetin alfa 450 IU/kg once a week (QW) in people with Anemia and Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Epoetin alfa 450 IU/kg once a week, Epoetin alfa 150 IU/kg 3 times a week and Epoetin alfa 450 IU/kg once a week (QW)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Any nonmyeloid tumor confirmed by cytology and/or histology
- Day 1 baseline hemoglobin (Hb) level <=11 g/dL
- Expected to receive at least 12 weeks of chemotherapy after enrollment into the study
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Who cannot join
- History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer
- History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment
- History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry
- Onset of seizures within 3 months before randomization or poorly controlled seizures
- Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy
- Specifically excluded concomitant medications or therapies including prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin [LMWH], except for prevention of central venous catheter thrombosis at doses specified in the protocol, direct thrombin inhibitors, or anti-platelet drugs [e.g., clopidogrel or ticlopidine]), except for prophylaxis in patients with known cardiovascular disease
About this study
Official title: A Randomized, Open-Label, Multicenter Study Evaluating Thrombovascular Events in Subjects With Cancer Receiving Chemotherapy and Administered Epoetin Alfa Once or Three Times a Week for the Treatment of Anemia
The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.
Read the detailed description
Epoetin alfa is an agent similar to a hormone produced in the kidney (ie, erythropoietin) that functions to increase the amount of red blood cells made in the bone marrow. This is a randomized (study drug assigned by chance), open-label (patients and their doctors will know the identity of study drug administered), safety study of 2 dosing regimens (doses and schedules) of epoetin alfa administered to patients with cancer who have chemotherapy-related anemia. Anemia is a lack of red blood cells that can result in symptoms of weakness, shortness of breath, fatigue, tiredness, and decreased activity. The primary outcome measure in the study is the number of patients in each treatment group with at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) reviewed by an independent adjudication committee from Day 1 (baseline or the day of the first dose) through Week 16. An external review of relevant clinical data and medical imaging studies by an Adjudication Committee will be performed in a blinded fashion for confirmation of TVEs. The Adjudication Committee will confirm TVEs by reviewing all images (X-ray, Computed tomography [CT] scan, ultrasound, Magnetic Resonance Imaging [MRI] scan, etc) and other diagnostic procedures auch as coagulation tests or electrocardiograms in combination with a clinical patient profile as described for each specific type of TVE. Only TVEs that are determined by the Adjudication Committee to be clinically relevant and objectively confirmed will be counted in the analysis for the primary endpoint. Approximately 500 patients, who have cancer, are receiving chemotherapy, and are anemic, will take part in the study. Patients will participate in the study for up to 32 weeks (this includes a 2-week screening period to determine eligibility for the study, a 26-week treatment period, and a 4-week follow-up period to have end-of-study assessments [tests] performed). The length of participation in the study depends on the length of time the patient is receiving chemotherapy and epoetin alfa; patients in the study may receive up to a maximum of 26 weeks of treatment with epoetin alfa. Patients will be randomly assigned (assigned by chance like flipping a coin) to 1 of 2 treatment groups (Epoetin Alfa QW or Epoetin Alfa TIW). Patients assigned to the Epoetin Alfa QW Group will receive epoetin alfa at an initial dosage of 450 IU/kg once a week and patients assigned to Epoetin Alfa TIW Group will receive epoetin alfa 150 IU/kg 3 times a week by subcutaneous (underneath the skin) injection. Injections will be given preferably on Monday for patients in the Epoetin Alfa QW Group and on Mondays, Wednesdays, and Fridays for patients in the Epoetin Alfa TIW Group. During the study, patients will visit the study center weekly to have a blood sample collected to measure the amount of hemoglobin (red blood cells) in the blood. Depending on the hemoglobin level, the dose of epoetin alfa may be increased or decreased. Regardless of treatment group, if anemia does not improve in patients after 4 weeks of treatment, the dose of epoetin alfa will be increased to 300 IU/kg 3 times a week. If anemia does not improve after 4 weeks at the increased dose level of epoetin alfa (300 IU/kg 3 times a week), treatment with epoetin alfa will be stopped. In addition, during the study, patients may also receive treatment with iron supplements if the level of iron in the blood is low. During the study, safety will be monitored by evaluating adverse events and findings from clinical laboratory tests, 12-lead electrocardiograms (ECGs), blood pressure measurements, and physical examinations. Patients will receive epoetin alfa at an initial dose of 450 IU/kg once a week or 150 IU/kg 3 times a week by subcutaneous injection, preferably in the abdomen, for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. Injections for Epoetin Alfa QW Group will be at the study center and for Epoetin TIW Group, the 1st weekly injection will be at the study center and the 2nd and 3rd weekly injections will be at the study center or at home by self-administration.
- Being tested
- Epoetin alfa 450 IU/kg once a week, Epoetin alfa 150 IU/kg 3 times a week, Epoetin alfa 450 IU/kg once a week (QW), Epoetin alfa 150 IU/kg 3 times a week (TIW)
- Keywords
- Epoetin alfa (EPREX, ERYPO)
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfa 450 IU/kg once a weekDrug
450 IU/kg once a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
Epoetin alfa 150 IU/kg 3 times a weekDrug
150 IU/kg 3 times a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
Epoetin alfa 450 IU/kg once a week (QW)Drug
450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks
Epoetin alfa 150 IU/kg 3 times a week (TIW)Drug
150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Epoetin alfa 450 IU/kg once a week (QW) 450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks Receives: Drug: Epoetin alfa 450 IU/kg once a week; Drug: Epoetin alfa 450 IU/kg once a week (QW) |
| 002 | Experimental | Epoetin alfa 150 IU/kg 3 times a week (TIW) 150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. Receives: Drug: Epoetin alfa 150 IU/kg 3 times a week; Drug: Epoetin alfa 150 IU/kg 3 times a week (TIW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16
Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.
Measured: from randomization through Week 16
Secondary outcomes (7)
Number of Positively Adjudicated Thrombovascular Events
The number of participants who have at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) during the study.
Measured: during the study (randomization through week 26)
Time to First Positively Adjudicated Thrombovascular Event
Analysis of time to first positively adjudicated thrombovascular event (TVE) measured from the date of randomization to the date of the first clinically relevant and objectively confirmed TVE as determined by the Adjudication Committee. Median time is non-estimable because of too few events, incidence was reported instead.
Measured: during the study (randomization through week 26)
Number of Suspected Thrombovascular Events
Number of participants who have at least 1 suspected thrombovascular events (TVEs) during the entire study. Suspected TVEs were defined as suspected TVEs during the entire study, whether clinically relevant and objectively confirmed by the Adjudication Committee or not, whether confirmed by the investigator or not.
Measured: during the study (randomization through week 26)
Time to First Suspected Thrombovascular Event
Analysis of time to first suspected thrombovascular event (TVE) measured from the date of randomization to the date of the first suspected TVE during the study. Median time is non-estimable because of too few events, incidence was reported instead.
Measured: during the study (randomization through week 26)
Mortality
Number of participants who died during the study.
Measured: during the study (randomization through week 26)
Number of Hemoglobin Responders
Hemoglobin response was defined as a hemoglobin increase of ≥2 g/dL from baseline or reaching a hemoglobin concentration of 12 g/dL, regardless of dose adjustment.
Measured: during the study (randomization through week 26)
Red Blood Cell Transfusions
The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study.
Measured: during the study (randomization through week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394991
- Sponsor's protocol ID
- CR010543
- Other IDs
- EPOANE4008
- Status last verified
- Apr 2012
- First submitted
- 10 Sep 2010
- Last updated
- 5 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Study Evaluating Thrombovascular Events in Subjects With Cancer Receiving Chemotherapy and Administered Epoetin Alfa Once or Three Times a Week for the Treatment of Anemia
- ClinicalTrials.gov ID
- NCT01394991
- Acronym / sponsor ID
- CR010543
- Keywords
- Epoetin alfa (EPREX, ERYPO)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Posted 15 Jul 2011
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 the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.
Detailed description
Epoetin alfa is an agent similar to a hormone produced in the kidney (ie, erythropoietin) that functions to increase the amount of red blood cells made in the bone marrow. This is a randomized (study drug assigned by chance), open-label (patients and their doctors will know the identity of study drug administered), safety study of 2 dosing regimens (doses and schedules) of epoetin alfa administered to patients with cancer who have chemotherapy-related anemia. Anemia is a lack of red blood cells that can result in symptoms of weakness, shortness of breath, fatigue, tiredness, and decreased activity. The primary outcome measure in the study is the number of patients in each treatment group with at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) reviewed by an independent adjudication committee from Day 1 (baseline or the day of the first dose) through Week 16. An external review of relevant clinical data and medical imaging studies by an Adjudication Committee will be performed in a blinded fashion for confirmation of TVEs. The Adjudication Committee will confirm TVEs by reviewing all images (X-ray, Computed tomography [CT] scan, ultrasound, Magnetic Resonance Imaging [MRI] scan, etc) and other diagnostic procedures auch as coagulation tests or electrocardiograms in combination with a clinical patient profile as described for each specific type of TVE. Only TVEs that are determined by the Adjudication Committee to be clinically relevant and objectively confirmed will be counted in the analysis for the primary endpoint. Approximately 500 patients, who have cancer, are receiving chemotherapy, and are anemic, will take part in the study. Patients will participate in the study for up to 32 weeks (this includes a 2-week screening period to determine eligibility for the study, a 26-week treatment period, and a 4-week follow-up period to have end-of-study assessments [tests] performed). The length of participation in the study depends on the length of time the patient is receiving chemotherapy and epoetin alfa; patients in the study may receive up to a maximum of 26 weeks of treatment with epoetin alfa. Patients will be randomly assigned (assigned by chance like flipping a coin) to 1 of 2 treatment groups (Epoetin Alfa QW or Epoetin Alfa TIW). Patients assigned to the Epoetin Alfa QW Group will receive epoetin alfa at an initial dosage of 450 IU/kg once a week and patients assigned to Epoetin Alfa TIW Group will receive epoetin alfa 150 IU/kg 3 times a week by subcutaneous (underneath the skin) injection. Injections will be given preferably on Monday for patients in the Epoetin Alfa QW Group and on Mondays, Wednesdays, and Fridays for patients in the Epoetin Alfa TIW Group. During the study, patients will visit the study center weekly to have a blood sample collected to measure the amount of hemoglobin (red blood cells) in the blood. Depending on the hemoglobin level, the dose of epoetin alfa may be increased or decreased. Regardless of treatment group, if anemia does not improve in patients after 4 weeks of treatment, the dose of epoetin alfa will be increased to 300 IU/kg 3 times a week. If anemia does not improve after 4 weeks at the increased dose level of epoetin alfa (300 IU/kg 3 times a week), treatment with epoetin alfa will be stopped. In addition, during the study, patients may also receive treatment with iron supplements if the level of iron in the blood is low. During the study, safety will be monitored by evaluating adverse events and findings from clinical laboratory tests, 12-lead electrocardiograms (ECGs), blood pressure measurements, and physical examinations. Patients will receive epoetin alfa at an initial dose of 450 IU/kg once a week or 150 IU/kg 3 times a week by subcutaneous injection, preferably in the abdomen, for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. Injections for Epoetin Alfa QW Group will be at the study center and for Epoetin TIW Group, the 1st weekly injection will be at the study center and the 2nd and 3rd weekly injections will be at the study center or at home by self-administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Epoetin alfa 450 IU/kg once a week, Drug: Epoetin alfa 450 IU/kg once a week (QW)Epoetin alfa 450 IU/kg once a week (QW) 450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks |
| 002 | Experimental | Drug: Epoetin alfa 150 IU/kg 3 times a week, Drug: Epoetin alfa 150 IU/kg 3 times a week (TIW)Epoetin alfa 150 IU/kg 3 times a week (TIW) 150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any nonmyeloid tumor confirmed by cytology and/or histology
- Day 1 baseline hemoglobin (Hb) level <=11 g/dL
- Expected to receive at least 12 weeks of chemotherapy after enrollment into the study
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Key exclusion criteria (6 listed)
- History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer
- History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment
- History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry
- Onset of seizures within 3 months before randomization or poorly controlled seizures
- Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy
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 |
|---|---|---|
| Epoetin alfa 450 IU/kg once a week450 IU/kg once a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. | Drug | 001 |
| Epoetin alfa 150 IU/kg 3 times a week150 IU/kg 3 times a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. | Drug | 002 |
| Epoetin alfa 450 IU/kg once a week (QW)450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks | Drug | 001 |
| Epoetin alfa 150 IU/kg 3 times a week (TIW)150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. | Drug | 002 |
Primary outcome
Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16
Time frame: from randomization through Week 16
Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.
7 secondary outcomes
Number of Positively Adjudicated Thrombovascular Events
Time frame: during the study (randomization through week 26)
Time to First Positively Adjudicated Thrombovascular Event
Time frame: during the study (randomization through week 26)
Number of Suspected Thrombovascular Events
Time frame: during the study (randomization through week 26)
Time to First Suspected Thrombovascular Event
Time frame: during the study (randomization through week 26)
Mortality
Time frame: during the study (randomization through week 26)
Number of Hemoglobin Responders
Time frame: during the study (randomization through week 26)
Red Blood Cell Transfusions
Time frame: during the study (randomization through week 26)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alfa 450 IU/kg once a week, Epoetin alfa 150 IU/kg 3 times a week and Epoetin alfa 450 IU/kg once a week (QW) in people with Anemia and Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 inclusion and 6 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 5 Apr 2012. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16 (time frame: from randomization through Week 16). 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 5 Apr 2012.