Cardiovascular DiseasesLIGHTNCT00993915

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

An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cardiovascular Diseases, Coronary Artery Disease
What is being tested?: Atorvastatin
How many people: 687 participants
Where: No sites listed yet
Study dates: Apr 2010to Dec 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Coronary atery disease, prevention of high risk cardiovascular complications with statins.

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Cardiovascular Diseases, Coronary Artery Disease
Being tested: Atorvastatin
Keywords: Coronary Artery Disease, Hyperlipidemia, Atorvastatin
Medical subject headings: Cardiovascular Diseases, Coronary Artery Disease, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00993915
Study group	Role	What they receive
Main group		Newly diagnosed or known coronary artery disease and known dislipidemia and high risk of cardiovascular complications Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit
Measured: Month 1
Change From Baseline in Lipid Parameters
Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline
Measured: Month 6
Percent Change From Baseline in Lipid Parameters
Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Dec 2011

First posted14 Oct 2009 (estimated)
Study startApr 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 687 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00993915
Sponsor's protocol ID: A2581185
Acronym: LIGHT
Status last verified: Feb 2021
First submitted: 13 Oct 2009
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00993915
Acronym / sponsor ID: LIGHT / A2581185
Conditions: Cardiovascular Diseases, Coronary Artery Disease
Keywords: Coronary Artery Disease, Hyperlipidemia, Atorvastatin
Study type: Observational
Recruitment status: Completed
Enrolment: 687 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 14 Oct 2009 (estimated)
Results: Posted 20 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Main group	–	Drug: AtorvastatinNewly diagnosed or known coronary artery disease and known dislipidemia and high risk of cardiovascular complications

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Coronary atery disease, prevention of high risk cardiovascular complications with statins.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtorvastatinAtorvastatin, 10- 80 mg, once daily, 6 month treatment	Drug	Main group

Primary outcome

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

3 secondary outcomes

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
Percent Change From Baseline in Lipid Parameters
Time frame: Month 6

Results and safety

Results posted to the registry on 20 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorvastatin	687	678

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

Time frame: Month 6. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Atorvastatin n = 592
Value	51.52 (47.50 to 55.52)

Population analysed: Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin	0 of 687 (0%)	9 of 687 (1.3%)	Not reported

Limitations and caveats (from the sponsor): The end of study final status of 3 participants was not completed and therefore defaulted to ongoing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Not yet recruitingPhase 2
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00993915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.