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

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00724477

First received: July 25, 2008

Last updated: February 3, 2010

Last verified: February 2010

History of Changes

Results First Received: November 24, 2009

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Condition:	Primary Hypercholesterolemia
Intervention:	Drug: INEGY

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Subjects Treated With INEGY	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).

Participant Flow: Overall Study

	Subjects Treated With INEGY
STARTED	1663 ^[1]
COMPLETED	1663
NOT COMPLETED	0

[1]	This safety population (SAF)analysed consisted of all patients who took at least one tablet of INEGY

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Subjects Treated With INEGY	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).

Baseline Measures

	Subjects Treated With INEGY
Number of Participants [units: participants]	1663
Age [units: years] Mean ± Standard Deviation	61.6 ± 10.4
Gender [units: participants]
Female	585
Male	1078
Region of Enrollment [units: participants]
France	1663

Outcome Measures

1. Primary:

Number of Participants Reaching the Targeted LDL-C Levels [ Time Frame: 1 to 3 months after starting treatment ]

Show Outcome Measure 1

Serious Adverse Events

Hide Serious Adverse Events

Time Frame	4 weeks to 3 months
Additional Description	Adverse events were recorded from the introduction of INEGY to the first assessment after introduction of INEGY

Reporting Groups

	Description
Subjects Treated With INEGY	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).

Serious Adverse Events

	Subjects Treated With INEGY
Total, serious adverse events
# participants affected / at risk	2/1663 (0.12%)
Endocrine disorders
Myocardial infarction ^{† 1}
# participants affected / at risk	1/1663 (0.06%)
# events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma ^{† 1}
# participants affected / at risk	1/1663 (0.06%)
# events	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (11.0)

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00724477 History of Changes
Other Study ID Numbers:	P05103
Study First Received:	July 25, 2008
Results First Received:	November 24, 2009
Last Updated:	February 3, 2010
Health Authority:	France: Commission nationale de l'Informatique et des Libertés

To Top