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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

Status: Terminated

Sponsored by: Pfizer

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

Summary

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: Other, Prospective

Primary outcome:

LDL and HDL-cholesterol

HDL/LDL ratio

Urine protein and albumin

Total cholesterol,triglycerides

Secondary outcome: Blood glucose or HbA1c

Detailed description: 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 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.

Eligibility

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

Criteria:

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.

Link to ClinicalStudyResults.org Posting:

Starting date: December 2007
Ending date: May 2008
Last updated: June 3, 2008

Page last updated: June 20, 2008

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