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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_016 | Other Identifier | Merck Registration Number |
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| Name | Class |
|---|---|
| Institute of Applied Economics Aps, Denmark | UNKNOWN |
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The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004_050, MK0653A-043; NCT00092677).
The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050, MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. No patient visits will occur. National cancer and death registries exist in 5 of the 7 countries that participated in the base SEAS trial. At the time of Follow-up study initiation, accessing the registry data in Ireland was not feasible due to local regulations and Cancer and Death registries did not exist in Germany. As a result, data will be collected only for all SEAS patients known to be alive at the end of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe/Simvastatin 10/40 mg | Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study | ||
| Placebo | Participants who received placebo in the base study |
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| Measure | Description | Time Frame |
|---|---|---|
| Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort | Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate. | up to 21 Months after the end of the SEAS (base) study |
| Measure | Description | Time Frame |
|---|---|---|
| Crude Rate of Death (Any Cause) - Follow-up Total Cohort | All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death. |
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Inclusion Criteria:
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The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25267716 | Result | Green A, Ramey DR, Emneus M, Iachina M, Stavem K, Bolin K, McNally R, Busch-Sorensen M, Willenheimer R, Egstrup K, Kesaniemi YA, Ray S, Basta N, Kent C, Pedersen TR. Incidence of cancer and mortality in patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. Am J Cardiol. 2014 Nov 15;114(10):1518-22. doi: 10.1016/j.amjcard.2014.08.016. Epub 2014 Aug 27. |
| Label | URL |
|---|---|
| Current view of trial on ClinicalTrials.gov | View source |
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Of the 1873 participants in the SEAS base study, 1392 were eligible for inclusion in this follow-up study. Of these 1392 participants, 33 were excluded due to incomplete base study data or because follow-up data could not be obtained, leaving 1359 participants in the follow-up study.
All participants from five countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who completed the SEAS base study and who were known to be alive at the end of the base study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe/Simvastatin 10/40 mg | Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study |
| FG001 | Placebo | Participantss who received placebo in the base study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe/Simvastatin 10/40 mg | Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study |
| BG001 | Placebo | Participants who received placebo in the base study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Crude Rate of Death (Any Cause) - Follow-up Total Cohort | All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death. | Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study. | Posted | Number | 95% Confidence Interval | per 100 participant-years | up to 21 Months after the end of the base study |
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No formal reporting or recording of adverse events was conducted during this observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ezetimibe/Simvastatin 10/40 mg | Participants who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| up to 21 Months after the end of the base study |
| Crude Rate of Death Due to Cancer - Follow-up Primary Cohort | All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer. | up to 21 Months after the end of the base study |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Placebo | Participants who received placebo in the base study |
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| Secondary | Crude Rate of Death Due to Cancer - Follow-up Primary Cohort | All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer. | Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period. | Posted | Number | 95% Confidence Interval | per 100 participant-years | up to 21 Months after the end of the base study |
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|
| Primary | Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort | Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate. | Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period. | Posted | Number | 95% Confidence Interval | per 100 participant-years | up to 21 Months after the end of the SEAS (base) study |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Participants who were assigned to the placebo cohort in the base study | 0 | 0 | 0 | 0 |
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.