Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study)

Conditions
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Hypertension and Cardiovascular Risk Factors

Intervention / Treatment
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* Drug: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic and Diastolic Blood Pressure | No efficacy results were available from this terminated study. | Baseline, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy,safety & tolerability of Caduet In Patients With Cardiovascular Risk Factors