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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

December 20, 2007
June 18, 2009
December 2007
May 2008   (final data collection date for primary outcome measure)
Change in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Urine protein and albumin [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
  • LDL and HDL-cholesterol [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
  • HDL/LDL ratio [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
  • Total cholesterol,triglycerides [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00579254 on ClinicalTrials.gov Archive Site
Not Provided
Blood glucose or HbA1c [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study)

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations

Hypertension and Cardiovascular Risk Factors
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00579254
A3841054
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP