A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

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 (A3841045) 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 therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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 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.
• 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

• Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
  • Time Frame: Week 6
    Safety Issue?: No
• Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
  • Time Frame: Week 6, baseline
    Safety Issue?: No

Secondary Measures

• Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
  • Time Frame: Week 4
    Safety Issue?: No
• Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.
  • Time Frame: Week 4
    Safety Issue?: No
• Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.
  • Time Frame: Week 6
    Safety Issue?: No
• Subjects With LDL-C < 100 mg/dL at Week 4
  • Time Frame: Week 4
    Safety Issue?: No
• Subjects With LDL-C < 100 mg/dL at Week 6
  • Time Frame: Week 6
    Safety Issue?: No
• Subjects With BP < 140/90 mmHg at Week 4
  • Time Frame: Week 4
    Safety Issue?: No
• Subjects With BP < 140/90 mmHg at Week 6
  • Time Frame: Week 6
    Safety Issue?: No
• Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change From Baseline to Week 4 in Pulse Rate
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
  • Time Frame: Week 6, baseline
    Safety Issue?: No
• Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
  • Time Frame: Week 6, baseline
    Safety Issue?: No
• Change From Baseline to Week 6 in Pulse Rate
  • Time Frame: Week 6, baseline
    Safety Issue?: No
• Change From Baseline in LDL at Week 4.
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change in Total Cholesterol (TC) From Baseline to Week 4.
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change From Baseline in Triglycerides (TG) to Week 4.
  • Time Frame: Week 4, baseline
    Safety Issue?: No
• Change From Baseline in LDL at Week 6.
  • Time Frame: Week 6, baseline
    Safety Issue?: No
• Change From Baseline in HDL at Week 6.
  • Time Frame: Week 6, baseline
    Safety Issue?: No
• Change From Baseline in Total Cholesterol (TC) to Week 6.
  • Time Frame: Week 6, baseline
    Safety Issue?: No
• Change From Baseline in Triglycerides (TG) at Week 6.
  • Time Frame: Week 6 , baseline
    Safety Issue?: No
• Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
  • Time Frame: Week 4, baseline
    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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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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