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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00579254 |
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Date of registration:
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20/12/2007 |
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Primary sponsor: |
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Public title:
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Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
EXCEL |
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Scientific title:
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Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study) |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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112 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00579254 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension and Cardiovascular Risk Factors
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Intervention(s)
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Drug: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)
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Primary Outcome(s)
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Change in Systolic and Diastolic Blood Pressure
[Time Frame: Baseline, 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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