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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993915
First Posted: October 14, 2009
Last Update Posted: January 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention
Cardiovascular Diseases Coronary Artery Disease Drug: Atorvastatin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit [ Time Frame: Month 6 ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit [ Time Frame: Month 1 ]
  • Change From Baseline in Lipid Parameters [ Time Frame: Month 6 ]
    Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline

  • Percent Change From Baseline in Lipid Parameters [ Time Frame: Month 6 ]
    Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).


Other Outcome Measures:
  • Change From Baseline in Lipid Parameters at 1 Month [ Time Frame: Month 1 ]
    Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline

  • Percent Change From Baseline in Lipid Parameters at 1 Month [ Time Frame: Month 1 ]
    Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).


Enrollment: 687
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Main group
Newly diagnosed or known coronary artery disease and known dislipidemia and high risk of cardiovascular complications
Drug: Atorvastatin
Atorvastatin, 10- 80 mg, once daily, 6 month treatment

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary atery disease, prevention of high risk cardiovascular complications with statins.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993915


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00993915     History of Changes
Other Study ID Numbers: A2581185
First Submitted: October 13, 2009
First Posted: October 14, 2009
Results First Submitted: November 21, 2012
Results First Posted: December 20, 2012
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Pfizer:
Coronary Artery Disease
Hyperlipidemia
Atorvastatin

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors