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Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension and Cardiovascular Risk Factors

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

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change in Systolic and Diastolic Blood Pressure

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2007
Last updated: June 18, 2009

Page last updated: August 20, 2015

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