Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
NCT00993915
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Patients, who eligible to sign informed consent;
- Patients with indications to lipid lowing therapy, according to local product document.
- Patients with CHD and high risk of CV complications (Diabetes Mellitus II, Myocardial Infarction, Heart Failure, Arterial Hypertension, ets) will be included into study;
- Patients with LDL levels: > 3,5 mmol/l
- Individual intolerance of atorvastatin, in accordance to local product document.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications | |||
| Official Title | Non Interventional (NI) Open Label Prospective Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Coronary atery disease, prevention of high risk cardiovascular complications with statins. | |||
| Condition |
| |||
| Intervention | Drug: Atorvastatin
Atorvastatin, 10- 80 mg, once daily, 6 month treatment | |||
| Study Groups/Cohorts | Main group
Newly diagnosed or known coronary artery disease and known dislipidemia and high risk of cardiovascular complications Intervention: Drug: Atorvastatin | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 687 | |||
| Original Estimated Enrollment | 700 | |||
| Actual Study Completion Date | December 2011 | |||
| Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
| |||
| Ages | 18 Years to 80 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00993915 | |||
| Other Study ID Numbers | A2581185 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2013 | |||