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OpenTrials
Completed

NCT Number: NCT00993915

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

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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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

Atorvastatin, 10- 80 mg, once daily, 6 month treatment

Primary outcomes

  1. Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit

    Time frame: Month 6

Secondary outcomes

  1. Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit

    Time frame: Month 1

  2. 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

  3. 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 outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Non Interventional (NI) Open Label Prospective Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications

Acronym: LIGHT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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