Full Text View
Tabular View
Study Results
Related Studies
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 ]


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Show More Information