Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | Ezetimibe was not mandatory and was prescribed as per routine prescription by physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Cholesterol (TC) at Month 3 | Baseline and Month 3 | |
| Change From Baseline in TC at Month 12 | Baseline and Month 12 | |
| Change From Baseline in LDL-C at Month 3 |
Not provided
Inclusion criteria:
with ezetimibe (longitudinal analyses). The treatment decision will be made prior to
and independent from inclusion of participants into this study.
- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Participants without adequate LDL-cholesterol reduction with a statin, representative cross-section across all regions/parts of Austria (federal provinces, urban/rural areas, office-based internists/general practitioners)
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23979353 | Derived | Pichler M, Lautsch D, Adler C, Bogl K, Drexel H, Eber B, Fauer C, Fochterle J, Foger B, Gansch K, Grafinger P, Lechleitner M, Ludvik B, Maurer G, Morz R, Paulweber B, Pfeiffer KP, Prager R, Stark G, Toplak H, Traindl O, Weitgasser R. Are there differences in LDL-C target value attainment in Austrian federal states? Yes! Wien Med Wochenschr. 2013 Dec;163(23-24):528-35. doi: 10.1007/s10354-013-0219-z. Epub 2013 Aug 27. | |
| 22856551 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and Month 3 |
| Change From Baseline in LDL-C at Month 12 | Baseline and Month 12 |
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | Baseline and Month 3 |
| Change From Baseline in HDL-C at Month 12 | Baseline and Month 12 |
| Change From Baseline in Triglycerides (TG) at Month 3 | Baseline and Month 3 |
| Change From Baseline in TG at Month 12 | Baseline and Month 12 |
| Derived |
| Eber B, Lautsch D, Fauer C, Drexel H, Pfeiffer KP, Traindl O, Pichler M. Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II. Curr Med Res Opin. 2012 Sep;28(9):1447-54. doi: 10.1185/03007995.2012.717919. Epub 2012 Aug 16. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively | Posted | Number | Participants | Up to 12 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Cholesterol (TC) at Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 3 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in TC at Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in LDL-C at Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 3 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in LDL-C at Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 3 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in HDL-C at Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Triglycerides (TG) at Month 3 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 3 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in TG at Month 12 | Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and Month 12 |
|
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen. | 3 | 1,682 | 0 | 1,682 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchial Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Not Reported |
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|