To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines...
Date First Received: February 28, 2006
Last Updated: April 17, 2007
Verified by: Pfizer, April 2007
Clinical Trial Phase: Phase 3 | Start Date: October 2004
Overall Status: Completed
Estimated Enrollment: 1250
Brief Summary
Official Title: “An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia.”
Condition Keyword(s):
Intervention(s):
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Amlodipine/Atorvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- To evaluate the number of patients who reach target blood pressure (BP) and
- LDL-C targets as defined by their governing guidelines.
Secondary Measures
- To assess changes from baseline to end of treatment for the following efficacy
- parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein
- cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure
- (SBP) and Diastolic Blood Pressue (DBP).
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients who are above target LDL-C and BP who are eligible for treatment
Exclusion Criteria:
- High liver enzymes
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00330785
Study ID Number: A3841018
ClinicalTrials.gov Identifier: NCT00330785
Health Authority: United Kingdom: Department of Health
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