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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00579254 |
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 |
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Hypertension and Cardiovascular Risk Factors |
Drug: CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg) |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study) |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations
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:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3841054 |
Study First Received: | December 20, 2007 |
Results First Received: | May 1, 2009 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00579254 History of Changes |
Health Authority: | India: Independent Ethics Committee |
Efficacy,safety & tolerability of Caduet In Patients With Cardiovascular Risk Factors |
Antimetabolites Antilipemic Agents Vascular Diseases Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin Amlodipine Hypertension |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Vascular Diseases Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Atorvastatin Hypertension |