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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00150384 |
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Date of registration:
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06/09/2005 |
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Primary sponsor: |
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Public title:
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Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population
CAPABLE |
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Scientific title:
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Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE) |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00150384 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- African American men and women with concurrent hypertension and dyslipidemia that is
either treated or untreated
- Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their
respective Cardiovascular Risk group determined at screening
Exclusion Criteria:
- Subjects currently being treated with concomitant amlodipine and atorvastatin
therapy, including Caduet
- Subjects with blood pressure at goal
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dyslipidemia
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Hypertension
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Intervention(s)
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Drug: Amlodipine/Atorvastatin
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Primary Outcome(s)
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To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)
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Secondary Outcome(s)
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To assess the percentage of subjects achieving treatment goals(JNC VII and NCEP) stratified by the final BP and lipid therapy doses, respectively, the change from baseline in lipid profile, SBP and DBP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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