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

  Show 51 Study Locations
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:
Dyslipidemias
Hypertension
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Calcium, Dietary
Contraceptives, Oral
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014