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

This study has been terminated.
(See the termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00579254
First received: December 20, 2007
Last updated: June 18, 2009
Last verified: May 2009
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: December 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579254

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00579254     History of Changes
Other Study ID Numbers: A3841054
Study First Received: December 20, 2007
Results First Received: May 1, 2009
Last Updated: June 18, 2009
Health Authority: India: Independent Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013