Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors - Study Results

Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors (EXCEL)

This study has been terminated.

( See the termination reason in detailed description. )

Study NCT00579254 Information provided by Pfizer

First Received: December 20, 2007 Last Updated: June 18, 2009 History of Changes

Study Type:	Observational
Study Design:	Cohort, Prospective
Condition:	Hypertension and Cardiovascular Risk Factors
Intervention:	Drug: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)

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
This was a phase 4, observational, open-label study conducted in patients who were prescribed singlepill Caduet by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.

Reporting Groups

	Description
Caduet	Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

Participant Flow: Overall Study

	Caduet
STARTED	112
COMPLETED	0
NOT COMPLETED	112
Lost to Follow-up	39
Discontinued when study terminated	73

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Caduet	Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

Baseline Measures

	Caduet
Number of Participants [units: participants]	112
Age [units: years] Mean ± Standard Deviation	54.7 ± 9.6
Gender [units: participants]
Female	41
Male	71

Outcome Measures

1. Primary:

Change in Systolic and Diastolic Blood Pressure [ Baseline, 24 weeks ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Change in Systolic and Diastolic Blood Pressure
Measure Description	No efficacy results were available from this terminated study.
Time Frame	Baseline, 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Caduet	Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

Measured Values

	Caduet
Number of Participants Analyzed [units: participants]	0
Change in Systolic and Diastolic Blood Pressure [units: mmHg (millimeters of mercury)] Mean ± Standard Deviation

No statistical analysis provided for Change in Systolic and Diastolic Blood Pressure

Serious Adverse Events

Show Serious Adverse Events

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: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

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
The objectives for this terminated study could not be assessed due to limited data available. (Efficacy parameters were to include BP, heart rate, lipid profile, urine albumin.)

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3841054
Study First Received:	December 20, 2007
Results First Received:	May 1, 2009
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00579254 History of Changes
Health Authority:	India: Independent Ethics Committee