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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemia
• Intervention / Treatment: Drug: Amlodipine besylate; Drug: Amlodipine besylate; Drug: Amlodipine besylate/atorvastatin calcium single pill combination; Drug: Amlodipine besylate/atorvastatin calcium single pill combination

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35216
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35234
      • Pfizer Investigational Site
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Pfizer Investigational Site
  • California
    • Garden Grove, California, United States, 92843
      • Pfizer Investigational Site
    • Mission Viejo, California, United States, 92692
      • Pfizer Investigational Site
    • Rancho Santa Margarita, California, United States, 92688
      • Pfizer Investigational Site
    • Torrance, California, United States, 90502
      • Pfizer Investigational Site
  • Florida
    • Gainesville, Florida, United States, 32605
      • Pfizer Investigational Site
    • Kissimmee, Florida, United States, 34741
      • Pfizer Investigational Site
    • Melbourne, Florida, United States, 32935
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33176
      • Pfizer Investigational Site
    • Safety Harbor, Florida, United States, 34695
      • Pfizer Investigational Site
    • Saint Petersburg, Florida, United States, 33701
      • Pfizer Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Pfizer Investigational Site
    • Tucker, Georgia, United States, 30084
      • Pfizer Investigational Site
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Pfizer Investigational Site
  • Kentucky
    • Erlanger, Kentucky, United States, 41018
      • Pfizer Investigational Site
  • Maine
    • Auburn, Maine, United States, 04210
      • Pfizer Investigational Site
  • Michigan
    • Warren, Michigan, United States, 48091
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Pfizer Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pfizer Investigational Site
    • Florissant, Missouri, United States, 63031
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68116-2004
      • Pfizer Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89015
      • Pfizer Investigational Site
    • Henderson, Nevada, United States, 89014
      • Pfizer Investigational Site
  • New Jersey
    • Belvidere, New Jersey, United States, 07823
      • Pfizer Investigational Site
    • Bridgewater, New Jersey, United States, 08807
      • Pfizer Investigational Site
    • Clifton, New Jersey, United States, 07013
      • Pfizer Investigational Site
    • Elizabeth, New Jersey, United States, 07202
      • Pfizer Investigational Site
    • Hillsborough, New Jersey, United States, 08844
      • Pfizer Investigational Site
    • Trenton, New Jersey, United States, 08618
      • Pfizer Investigational Site
  • New York
    • Brooklyn, New York, United States, 11229
      • Pfizer Investigational Site
    • Buffalo, New York, United States, 14209
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45219
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74136
      • Pfizer Investigational Site
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Pfizer Investigational Site
    • Lansdale, Pennsylvania, United States, 19446
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19146
      • Pfizer Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Pfizer Investigational Site
  • South Carolina
    • Goose Creek, South Carolina, United States, 29445
      • Pfizer Investigational Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Pfizer Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Pfizer Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75235
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030-2324
      • Pfizer Investigational Site
    • Plano, Texas, United States, 75093
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78238
      • Pfizer Investigational Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Amlodipine besylate; Amlodipine besylate 5 mg; Drug: Amlodipine besylate; Amlodipine besylate 10 mg
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.	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
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.	Drug: Amlodipine besylate; Amlodipine besylate 5 mg; Drug: Amlodipine besylate; Amlodipine besylate 10 mg
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 .	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Subjects With BP < 140/90 mmHg at Week 4	Subjects achieving BP goal of <140/90 mmHg at week 4	Week 4
Subjects With BP < 140/90 mmHg at Week 6	Subjects achieving BP goal of <140/90 mmHg at week 6	Week 6
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).	Mean at observation minus mean at baseline	Week 4, baseline
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)	Mean at observation minus mean at baseline	Week 4, baseline
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
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)	Mean change at observation minus mean baseline.	Week 6, baseline
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)	Change from mean at observation minus mean at baseline	Week 6, baseline
Change From Baseline to Week 6 in Pulse Rate	Mean at observation minus mean at baseline	Week 6, baseline
Change From Baseline in LDL at Week 4.	Change: mean of observation minus mean at baseline.	Week 4, baseline
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.	Mean change at observation minus baseline.	Week 4, baseline
Change in Total Cholesterol (TC) From Baseline to Week 4.	Mean change at observation minus baseline.	Week 4, baseline
Change From Baseline in Triglycerides (TG) to Week 4.	Mean change at observation minus baseline	Week 4, baseline
Change From Baseline in LDL at Week 6.	Mean change at observation minus baseline.	Week 6, baseline
Change From Baseline in HDL at Week 6.	Mean change at observation minus baseline.	Week 6, baseline
Change From Baseline in Total Cholesterol (TC) to Week 6.	Mean change at observation minus baseline.	Week 6, baseline
Change From Baseline in Triglycerides (TG) at Week 6.	Mean change at observation minus mean baseline.	Week 6 , baseline
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: December 13, 2006
• First Submitted That Met QC Criteria: December 13, 2006
• First Posted (Estimate): December 15, 2006

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Atorvastatin; Amlodipine; Calcium; Calcium, Dietary
• Other Study ID Numbers: A3841045