Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

Hypertension and Cardiovascular Risk Factors Clinical Trial

— EXCEL  

Official title:

Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00579254
• Other study ID #: A3841054
• Status: Terminated
• Start date: December 2007
• Est. completion date: May 2008

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension and Cardiovascular Risk Factors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic and Diastolic Blood Pressure	No efficacy results were available from this terminated study.	Baseline, 24 weeks

External Links

•   To obtain contact information for a study center near you, click here.