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In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant diseases and cardiovascular risk factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main group | Newly diagnosed or known coronary artery disease and known dislipidemia and high risk of cardiovascular complications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin, 10- 80 mg, once daily, 6 month treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit | Month 1 | |
| Change From Baseline in Lipid Parameters | Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lipid Parameters at 1 Month | Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline | Month 1 |
| Percent Change From Baseline in Lipid Parameters at 1 Month |
Inclusion Criteria:
Exclusion Criteria:
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Coronary atery disease, prevention of high risk cardiovascular complications with statins.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Month 6 |
| Percent Change From Baseline in Lipid Parameters | Percent change from baseline calculated as: 100*(change at Month X)/(baseline value). | Month 6 |
Percent change from baseline calculated as: 100*(change at Month X)/(baseline value). |
| Month 1 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Total cholesterol | Number of participants with available data = 673 | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
| ||||||||||||||||||||||||
| Low-density lipoprotein (LDL) cholesterol | Number of participants with available data = 661 | Mean | Standard Deviation | mg/dL |
| ||||||||||||||||||||||||
| High-density lipoprotein (HDL) cholesterol | Number of participants with available data = 633 | Mean | Standard Deviation | mg/dL |
| ||||||||||||||||||||||||
| Triglycerides | Number of participants with available data = 664 | Mean | Standard Deviation | mg/dL |
|
| 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 | Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit | Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit | Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure. | Posted | Month 1 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lipid Parameters | Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline | FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dL | Month 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Lipid Parameters | Percent change from baseline calculated as: 100*(change at Month X)/(baseline value). | FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure. | Posted | Mean | 95% Confidence Interval | percent change | Month 6 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Lipid Parameters at 1 Month | Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline | Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure. | Posted | Month 1 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Lipid Parameters at 1 Month | Percent change from baseline calculated as: 100*(change at Month X)/(baseline value). | Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure. | Posted | Month 1 |
|
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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 | Atorvastatin | The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily. | 0 | 687 | 9 | 687 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
The end of study final status of 3 participants was not completed and therefore defaulted to ongoing.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Title | Measurements |
|---|---|
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