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Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

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NCT00579254

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension and Cardiovascular Risk Factors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients who have been prescribed single pill Caduet are eligible to participate in this
study. Patients will be treated in this study according to prevailing local clinical
practice following the locally approved product labeled recommendations.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component
of this medication,

- Active liver disease or unexplained persistent elevations of serum transaminases
exceeding three times the upper limit of normal,

- Or who are pregnant, breast-feeding, or of childbearing potential who are not using
adequate contraceptive measures. Amlodipine/atorvastatin should be administered to
women of childbearing age only when such patients are highly unlikely to conceive and
have been informed of the potential hazards to the fetus.

NCT00579254
Pfizer
Terminated
Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study)
To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the administration of the amlodipine/atorvastatin single pill to be appropriate

Patients who have been prescribed single pill Caduet are eligible to participate in this study. The treating physician will obtain written informed consent from each subject or the subject's legally acceptable representative before any study-specific activity is performed.

The study terminated on May 5, 2008. The decision to terminate was due to inability to achieve study timelines and undue delay in obtaining IEC/IRB permission at some sites. No safety or efficacy issues caused the decision to terminate.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations
Hypertension and Cardiovascular Risk Factors
Drug: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)
Patients who have been treated with Caduet 5/10 or 5/20 mg single pill treatment, based on their clinical conditions and latest locally approved packet insert recommendations will be eligible to be enrolled to this study
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients who have been prescribed single pill Caduet are eligible to participate in this study. Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

Exclusion Criteria:

  • Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of this medication,
  • Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal,
  • Or who are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Amlodipine/atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00579254
A3841054
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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