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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00579254
Recruitment Status : Terminated (See the termination reason in detailed description.)
First Posted : December 24, 2007
Results First Posted : June 19, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:

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

  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

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.

Baseline Measures
   Caduet 
Overall Participants Analyzed 
[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   [ Time Frame: Baseline, 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.)


  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:
unchecked 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.
unchecked 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.


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



Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00579254     History of Changes
Other Study ID Numbers: A3841054
First Submitted: December 20, 2007
First Posted: December 24, 2007
Results First Submitted: May 1, 2009
Results First Posted: June 19, 2009
Last Update Posted: June 25, 2009