Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemias With Hypertension; Angina With Dyslipidemia
Intervention: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg) (Drug)
Phase: Phase 4
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
Official title: Real Life Experience With Caduet Evaluating Effectiveness, Safety And Tolerability In The Management Of Cardiovascular Risk Factors (EXCEL Study)
Study design: Other, Prospective
LDL and HDL-cholesterol
Urine protein and albumin
Secondary outcome: Blood glucose or HbA1c
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 and they will be observed for 6 months following study
recruitment. 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
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.
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.
- 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
To obtain contact information for a study center near you, click here.
Link to ClinicalStudyResults.org Posting:
Starting date: December 2007
Ending date: May 2008
Last updated: June 3, 2008