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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00412113
First received: December 13, 2006
Last updated: November 12, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Hypertension
Drug: Amlodipine besylate
Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk [ Time Frame: Week 6, baseline ] [ Designated as safety issue: No ]

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

Enrollment: 245
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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 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 5/20 mg

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412113

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
Pfizer Investigational Site
Birmingham, Alabama, United States, 35234
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85206
United States, California
Pfizer Investigational Site
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
United States, Florida
Pfizer Investigational Site
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
St. Petersburg, Florida, United States, 33701
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30904
Pfizer Investigational Site
Tucker, Georgia, United States, 30084
United States, Indiana
Pfizer Investigational Site
South Bend, Indiana, United States, 46601
United States, Kentucky
Pfizer Investigational Site
Erlanger, Kentucky, United States, 41018
United States, Maine
Pfizer Investigational Site
Auburn, Maine, United States, 04210
United States, Michigan
Pfizer Investigational Site
Warren, Michigan, United States, 48091
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63017
Pfizer Investigational Site
Florissant, Missouri, United States, 63031
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68116-2004
United States, Nevada
Pfizer Investigational Site
Henderson, Nevada, United States, 89014
Pfizer Investigational Site
Henderson, Nevada, United States, 89015
United States, New Jersey
Pfizer Investigational Site
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
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11229
Pfizer Investigational Site
Buffalo, New York, United States, 14209
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Pfizer Investigational Site
Bensalem, Pennsylvania, United States, 19020
Pfizer Investigational Site
Lansdale, Pennsylvania, United States, 19446
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19146
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02904
United States, South Carolina
Pfizer Investigational Site
Goose Creek, South Carolina, United States, 29445
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
Bristol, Tennessee, United States, 37620
Pfizer Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Pfizer Investigational Site
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
United States, Virginia
Pfizer Investigational Site
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00412113     History of Changes
Other Study ID Numbers: A3841045
Study First Received: December 13, 2006
Results First Received: April 13, 2009
Last Updated: November 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Contraceptives, Oral
Atorvastatin
Amlodipine, atorvastatin drug combination
Calcium, Dietary
Amlodipine
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Bone Density Conservation Agents
Antihypertensive Agents
Cardiovascular Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents

ClinicalTrials.gov processed this record on September 16, 2014