Official Title: “A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed To Evaluate The Efficacy Of An Aggressive Multi-Risk Factor Management Strategy With Caduet Versus A Guideline-Based Approach In Achieving Blood Pressure And Lipid Goals In Hypertensive Subjects With Additional Risk Factors.”

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus TLC regimen) will result in greater percentage of patients achieving blood pressure and LDL-C goals compared with a JNC 7/NCEP ATP III guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Amlodipine besylate/atorvastatin calcium single pill combination
  • Amlodipine/atorvastatin single pill combination 10/20 mg
• Drug: Amlodipine besylate/atorvastatin calcium single pill combination
  • Amlodipine/atorvastatin single pill combination 5/20 mg
• Drug: Amlodipine besylate
  • Amlodipine besylate 5 mg
• Drug: Amlodipine besylate
  • Amlodipine besylate 10 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Caduet 10/20mg
  • Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.
• Active Comparator: Norvasc 10 mg
  • Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.
• Active Comparator: Norvasc 5 mg
  • Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.
• Experimental: Caduet 5/20mg
  • Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

Primary Measures

• The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 6.
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• The Framingham predicted 10-year risk of CHD outcomes based on subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure collected at Week 4
  • Time Frame: 6 weeks
    Safety Issue?: No
• & 6.
  • Time Frame: 6 weeks
    Safety Issue?: No
• The percentage of subjects achieving BP goal < 140/90 mmHg at Week 4 and 6.
  • Time Frame: 4 and 6 weeks
    Safety Issue?: No
• The change from Baseline in LDL-C, TC, triglycerides, HDL-C, HDL-C/LDL-C ratio, SBP, diastolic blood pressure, and pulse rate at Week 4 and 6.
  • Time Frame: 4 and 6 weeks
    Safety Issue?: No
• The safety profile of Caduet plus TLC based regimen versus Norvasc plus TLC based regimen.
  • Time Frame: 6 weeks
    Safety Issue?: No
• The percentage of subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III Update LDL-C goal <100 mg/dL at Week 4.
  • Time Frame: 4 weeks
    Safety Issue?: No
• The percentage of subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4 and Week 6.
  • Time Frame: 4 and 6 weeks
    Safety Issue?: No
• The percentage of subjects achieving LDL-C goal < 100 mg/dL at Week 4 and 6.
  • Time Frame: 4 and 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion Criteria:

• Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
• Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
• Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular
• Disease (PVD)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00412113

Study ID Number: A3841045

ClinicalTrials.gov Identifier: NCT00412113

Health Authority: United States: Food and Drug Administration

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