Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications

Coronary Artery Disease Clinical Trial

— LIGHT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993915
• Other study ID #: A2581185
• Status: Completed
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 687
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individual intolerance of atorvastatin, in accordance to local product document.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin
Atorvastatin, 10- 80 mg, once daily, 6 month treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Percent Change From Baseline in Lipid Parameters at 1 Month	Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).	Month 1
Primary	Percentage of Participants Achieving LDL Level Less Than or Equal to (=) 100 mg/dL at the 6 Month Visit		Month 6
Secondary	Percentage of Participants Achieving LDL Level = 100 mg/dL at the 1 Month Visit		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	Month 6
Secondary	Percent Change From Baseline in Lipid Parameters	Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).	Month 6

External Links

•   To obtain contact information for a study center near you, click here.