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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:
ClinicalTrials.gov Identifier:
NCT00412113
First Posted: December 15, 2006
Last Update Posted: November 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk [ Time Frame: Week 6, baseline ]

Secondary Outcome Measures:
  • Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4 [ Time Frame: Week 4 ]
  • Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4. [ Time Frame: Week 4 ]
  • Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6. [ Time Frame: Week 6 ]
  • Subjects With LDL-C < 100 mg/dL at Week 4 [ Time Frame: Week 4 ]
  • Subjects With LDL-C < 100 mg/dL at Week 6 [ Time Frame: Week 6 ]
  • Subjects With BP < 140/90 mmHg at Week 4 [ Time Frame: Week 4 ]
  • Subjects With BP < 140/90 mmHg at Week 6 [ Time Frame: Week 6 ]
  • Change From Baseline to Week 4 in Systolic Blood Pressure (SBP). [ Time Frame: Week 4, baseline ]
  • Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) [ Time Frame: Week 4, baseline ]
  • Change From Baseline to Week 4 in Pulse Rate [ Time Frame: Week 4, baseline ]
  • Change From Baseline to Week 6 in Systolic Blood Pressure (SBP) [ Time Frame: Week 6, baseline ]
  • Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP) [ Time Frame: Week 6, baseline ]
  • Change From Baseline to Week 6 in Pulse Rate [ Time Frame: Week 6, baseline ]
  • Change From Baseline in LDL at Week 4. [ Time Frame: Week 4, baseline ]
  • Change From Baseline in High Density Lipoprotein (HDL) at Week 4. [ Time Frame: Week 4, baseline ]
  • Change in Total Cholesterol (TC) From Baseline to Week 4. [ Time Frame: Week 4, baseline ]
  • Change From Baseline in Triglycerides (TG) to Week 4. [ Time Frame: Week 4, baseline ]
  • Change From Baseline in LDL at Week 6. [ Time Frame: Week 6, baseline ]
  • Change From Baseline in HDL at Week 6. [ Time Frame: Week 6, baseline ]
  • Change From Baseline in Total Cholesterol (TC) to Week 6. [ Time Frame: Week 6, baseline ]
  • Change From Baseline in Triglycerides (TG) at Week 6. [ Time Frame: Week 6 , baseline ]
  • Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk. [ Time Frame: Week 4, baseline ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412113


  Show 51 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00412113     History of Changes
Other Study ID Numbers: A3841045
First Submitted: December 13, 2006
First Posted: December 15, 2006
Results First Submitted: April 13, 2009
Results First Posted: November 6, 2009
Last Update Posted: November 20, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Atorvastatin Calcium
Amlodipine, atorvastatin drug combination
Amlodipine
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents