Primary HypercholesterolemiaNCT00724477

Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)

An observational study of Primary Hypercholesterolemia, run by Organon and Co.

Completed

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

Trial summary

The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Hypercholesterolemia
What is being tested?: INEGY
Type of treatment: Pill or oral medicine
How many people: 1,663 participants
Where: No sites listed yet
Study dates: Oct 2007to Aug 2008
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY

Who may be able to join

man or woman aged over 18;
patient suffering from primary hypercholesterolemia;
patient justifying treatment with INEGY® (2nd intention);
patient currently treated with INEGY® for at least 4 weeks;
patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy;
patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment.

Who cannot join

patient not previously treated with a statin;
patient previously treated with a combination of hypolipemics;
patient treated with INEGY® as first intention;
patient treated with INEGY® for less than 4 weeks;
patient already included in this study.

About this study

Official title: PRAGMATIC (This is the True Official Title of the Protocol for This Study)

Read the detailed description

The type of patient sampling used was consecutive patient sampling

Conditions: Primary Hypercholesterolemia
Being tested: INEGY

What participants receive

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

INEGYDrug
Also called SCH 465981
Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks

Study groups in NCT00724477
Study group	Role	What they receive
Subjects treated with INEGY		Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY Receives: Drug: INEGY

What is being measured

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

Number of Participants Reaching the Targeted LDL-C Levels
A subject was considered to have met targeted LDL-C levels (been controlled) if:
- subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,
- subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,
- subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,
- subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,
- subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L.
Measured: 1 to 3 months after starting treatment

Timeline

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

Oct 2007Aug 2008

First posted29 Jul 2008 (estimated)
Study startOct 2007
Primary completionAug 2008
Study completionAug 2008

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 Primary HypercholesterolemiaStudies 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: Cohort
Time perspective: Retrospective
Enrolment: 1,663 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00724477
Sponsor's protocol ID: P05103
Status last verified: Feb 2022
First submitted: 25 Jul 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingObservational study
To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
Essential Hypertension, Primary Hypercholesterolemia
Not yet recruitingPhase 3
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Not yet recruitingPhase 3
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemia or Mixed Hyperlipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRAGMATIC (This is the True Official Title of the Protocol for This Study)
ClinicalTrials.gov ID: NCT00724477
Acronym / sponsor ID: P05103
Conditions: Primary Hypercholesterolemia
Study type: Observational
Recruitment status: Completed
Enrolment: 1,663 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 29 Jul 2008 (estimated)
Results: Posted 26 Feb 2010

Clinical summary

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

Detailed description

The type of patient sampling used was consecutive patient sampling

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Subjects treated with INEGY	–	Drug: INEGYSubjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY

Key inclusion criteria (6 listed)

man or woman aged over 18;
patient suffering from primary hypercholesterolemia;
patient justifying treatment with INEGY® (2nd intention);
patient currently treated with INEGY® for at least 4 weeks;
patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy;

Key exclusion criteria (5 listed)

patient not previously treated with a statin;
patient previously treated with a combination of hypolipemics;
patient treated with INEGY® as first intention;
patient treated with INEGY® for less than 4 weeks;
patient already included in this study.

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
INEGYAlso: SCH 465981Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks	Drug	Subjects treated with INEGY

Primary outcome

Number of Participants Reaching the Targeted LDL-C Levels
Time frame: 1 to 3 months after starting treatment
A subject was considered to have met targeted LDL-C levels (been controlled) if: * subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L, * subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L, * subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L, * subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L, * subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L.

Results and safety

Results posted to the registry on 26 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Treated With INEGY	1,663	1,663

Primary outcome: Number of Participants Reaching the Targeted LDL-C Levels

Time frame: 1 to 3 months after starting treatment. Number. Unit: Participants

Measure	Subjects Treated With INEGY n = 1354
Value	740

Population analysed: This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.

Adverse events

Time frame: 4 weeks to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Treated With INEGY	2 of 1,663 (0.1%)	0 of 1,663 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingObservational study
To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
Essential Hypertension, Primary Hypercholesterolemia
Not yet recruitingPhase 3
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Not yet recruitingPhase 3
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemia or Mixed Hyperlipidemia

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hypercholesterolemia, run by Organon and Co.

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 6 inclusion and 5 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 9 Feb 2022. 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 26 Feb 2010). 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?

Number of Participants Reaching the Targeted LDL-C Levels (time frame: 1 to 3 months after starting treatment). 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 NCT00724477.

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 9 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.