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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00724477
• Collaborator: (none)
• Enrollment: 1,663
• Duration (Months): 10

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia	Drug: INEGY

Detailed Description

The type of patient sampling used was consecutive patient sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 1663 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: PRAGMATIC (This is the True Official Title of the Protocol for This Study)
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Subjects treated with INEGY Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY	Drug: INEGY; Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks; Other Names: SCH 465981

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reaching the Targeted LDL-C Levels [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00724477
• Other Study ID Numbers: P05103
• First Posted: Jul 29, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

Participant Flow

Arm/Group Title	Subjects Treated With INEGY
Arm/Group Description	Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
Period Title: Overall Study
STARTED	1663
COMPLETED	1663
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Subjects Treated With INEGY
Arm/Group Description	Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
Overall Participants	1663
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (10.4)
Sex: Female, Male (Count of Participants)
Female	585 35.2%
Male	1078 64.8%
Region of Enrollment (participants) [Number]
France	1663 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reaching the Targeted LDL-C Levels
Description	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.
Time Frame	1 to 3 months after starting treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Treated With INEGY
Arm/Group Description	Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
Measure Participants	1354
Number [Participants]	740 44.5%

Adverse Events

Time Frame	4 weeks to 3 months
Adverse Event Reporting Description	Adverse events were recorded from the introduction of INEGY to the first assessment after introduction of INEGY
Arm/Group Title	Subjects Treated With INEGY
Arm/Group Description	Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
All Cause Mortality
	Subjects Treated With INEGY
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects Treated With INEGY
	Affected / at Risk (%)	# Events
Total	2/1663 (0.1%)
Endocrine disorders
Myocardial infarction	1/1663 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma	1/1663 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Subjects Treated With INEGY
	Affected / at Risk (%)	# Events
Total	0/1663 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The results of this non-interventional study can be published or presented by members of the scientific committee after revision and agreement by Schering-Plough, and in such a way that the confidential information and industrial property are not revealed. Before publication or presentation, a copy of the final text must be sent by the member(s) of the scientific committee to Schering-Plough for comment.