An Observational Study of Statin Treatment Induced HDL Changes

NCT ID: NCT01551784

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An observational study of statin treatment induced HDL changes - effect on cardiovascular disease

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Statin treatment Cardiovascular disease Statin treatment induced HDL changes and the effect on cardiovascular disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Started treatment with statins within the observation period (2004-2010)
* The patient must have valid baseline and follow-up measurements for HDL-C and LDL-C.

Exclusion Criteria

* Malignancy Alcohol abuse/alcohol dependence
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gunnar Johansson, MD, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala Sweden

Ron Herings, DR, ASSOC PROF

Role: PRINCIPAL_INVESTIGATOR

Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-CSE-CRE-2011/1

Identifier Type: -

Identifier Source: org_study_id