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NCT00412113 Clinical Trial

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

Hypertension Clinical Trial

— TOGETHER  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00412113
Other study ID # A3841045
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2007
Est. completion date April 2008

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Pfizer Investigational Site Auburn Maine
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Belvidere New Jersey
United States Pfizer Investigational Site Bensalem Pennsylvania
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Bridgewater New Jersey
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Chesapeake Virginia
United States Pfizer Investigational Site Chesterfield Missouri
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clifton New Jersey
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Elizabeth New Jersey
United States Pfizer Investigational Site Erlanger Kentucky
United States Pfizer Investigational Site Florissant Missouri
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Garden Grove California
United States Pfizer Investigational Site Goose Creek South Carolina
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Hillsborough New Jersey
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Kingsport Tennessee
United States Pfizer Investigational Site Kissimmee Florida
United States Pfizer Investigational Site Lansdale Pennsylvania
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Mission Viejo California
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Plano Texas
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Rancho Santa Margarita California
United States Pfizer Investigational Site Safety Harbor Florida
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site South Bend Indiana
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Trenton New Jersey
United States Pfizer Investigational Site Tucker Georgia
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Warren Michigan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL) Week 6
Primary Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline. Week 6, baseline
Secondary Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4 Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4. Week 4
Secondary Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4. 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. Week 4
Secondary Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6. Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6. Week 6
Secondary Subjects With LDL-C < 100 mg/dL at Week 4 Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4. Week 4
Secondary Subjects With LDL-C < 100 mg/dL at Week 6 Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6. Week 6
Secondary Subjects With BP < 140/90 mmHg at Week 4 Subjects achieving BP goal of <140/90 mmHg at week 4 Week 4
Secondary Subjects With BP < 140/90 mmHg at Week 6 Subjects achieving BP goal of <140/90 mmHg at week 6 Week 6
Secondary Change From Baseline to Week 4 in Systolic Blood Pressure (SBP). Mean at observation minus mean at baseline Week 4, baseline
Secondary Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) Mean at observation minus mean at baseline Week 4, baseline
Secondary Change From Baseline to Week 4 in Pulse Rate Mean at observation minus mean at baseline measured in beats per minute (bpm). Week 4, baseline
Secondary Change From Baseline to Week 6 in Systolic Blood Pressure (SBP) Mean change at observation minus mean baseline. Week 6, baseline
Secondary Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP) Change from mean at observation minus mean at baseline Week 6, baseline
Secondary Change From Baseline to Week 6 in Pulse Rate Mean at observation minus mean at baseline Week 6, baseline
Secondary Change From Baseline in LDL at Week 4. Change: mean of observation minus mean at baseline. Week 4, baseline
Secondary Change From Baseline in High Density Lipoprotein (HDL) at Week 4. Mean change at observation minus baseline. Week 4, baseline
Secondary Change in Total Cholesterol (TC) From Baseline to Week 4. Mean change at observation minus baseline. Week 4, baseline
Secondary Change From Baseline in Triglycerides (TG) to Week 4. Mean change at observation minus baseline Week 4, baseline
Secondary Change From Baseline in LDL at Week 6. Mean change at observation minus baseline. Week 6, baseline
Secondary Change From Baseline in HDL at Week 6. Mean change at observation minus baseline. Week 6, baseline
Secondary Change From Baseline in Total Cholesterol (TC) to Week 6. Mean change at observation minus baseline. Week 6, baseline
Secondary Change From Baseline in Triglycerides (TG) at Week 6. Mean change at observation minus mean baseline. Week 6 , baseline
Secondary Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk. Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline. Week 4, baseline
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