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Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors (EXCEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00579254
Recruitment Status : Terminated (See the termination reason in detailed description.)
First Posted : December 24, 2007
Results First Posted : June 19, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Hypertension and Cardiovascular Risk Factors Drug: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg) Phase 4

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.


Study Design

Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study)
Study Start Date : December 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Change in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline, 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579254


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00579254     History of Changes
Other Study ID Numbers: A3841054
First Posted: December 24, 2007    Key Record Dates
Results First Posted: June 19, 2009
Last Update Posted: June 25, 2009
Last Verified: May 2009

Keywords provided by Pfizer:
Efficacy,safety & tolerability of Caduet In Patients With Cardiovascular Risk Factors

Additional relevant MeSH terms:
Atorvastatin Calcium
Amlodipine, atorvastatin drug combination
Amlodipine
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents