Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia

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):

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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Link to ClinicalStudyResults.org posting

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