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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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
Time Frame: Week 6, baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Week 4
Subjects achieving BP goal of <140/90 mmHg at week 4
Week 4
Subjects With BP < 140/90 mmHg at Week 6
Time Frame: 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).
Time Frame: Week 4, baseline
Mean at observation minus mean at baseline
Week 4, baseline
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Time Frame: Week 4, baseline
Mean at observation minus mean at baseline
Week 4, baseline
Change From Baseline to Week 4 in Pulse Rate
Time Frame: Week 4, baseline
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)
Time Frame: Week 6, baseline
Mean change at observation minus mean baseline.
Week 6, baseline
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
Time Frame: Week 6, baseline
Change from mean at observation minus mean at baseline
Week 6, baseline
Change From Baseline to Week 6 in Pulse Rate
Time Frame: Week 6, baseline
Mean at observation minus mean at baseline
Week 6, baseline
Change From Baseline in LDL at Week 4.
Time Frame: Week 4, baseline
Change: mean of observation minus mean at baseline.
Week 4, baseline
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
Time Frame: Week 4, baseline
Mean change at observation minus baseline.
Week 4, baseline
Change in Total Cholesterol (TC) From Baseline to Week 4.
Time Frame: Week 4, baseline
Mean change at observation minus baseline.
Week 4, baseline
Change From Baseline in Triglycerides (TG) to Week 4.
Time Frame: Week 4, baseline
Mean change at observation minus baseline
Week 4, baseline
Change From Baseline in LDL at Week 6.
Time Frame: Week 6, baseline
Mean change at observation minus baseline.
Week 6, baseline
Change From Baseline in HDL at Week 6.
Time Frame: Week 6, baseline
Mean change at observation minus baseline.
Week 6, baseline
Change From Baseline in Total Cholesterol (TC) to Week 6.
Time Frame: Week 6, baseline
Mean change at observation minus baseline.
Week 6, baseline
Change From Baseline in Triglycerides (TG) at Week 6.
Time Frame: Week 6 , baseline
Mean change at observation minus mean baseline.
Week 6 , baseline
Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
Time Frame: Week 4, baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3841045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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