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

December 13, 2006
November 12, 2009
January 2007
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 6.
Complete list of historical versions of study NCT00412113 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The percentage of subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III Update LDL-C goal <100 mg/dL at Week 4.
  • The percentage of 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 and Week 6.
  • The Framingham predicted 10-year risk of CHD outcomes based on subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol
  • and systolic blood pressure collected at Week 4 and 6.
  • The percentage of subjects achieving BP goal < 140/90 mmHg at Week 4 and 6.
  • The change from Baseline in LDL-C, TC, triglycerides, HDL-C, HDL-C/LDL-C ratio, SBP, diastolic blood pressure, and pulse rate at Week 4 and 6.
  • The safety profile of Caduet plus TLC based regimen versus Norvasc plus TLC based regimen.
Not Provided
Not Provided
 
A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dyslipidemia
  • Hypertension
  • Drug: Amlodipine besylate
    Amlodipine besylate 5 mg
  • Drug: Amlodipine besylate/atorvastatin calcium single pill combination
    Amlodipine/atorvastatin single pill combination 10/20 mg
  • Drug: Amlodipine besylate
    Amlodipine besylate 10 mg
  • Drug: Amlodipine besylate/atorvastatin calcium single pill combination
    Amlodipine/atorvastatin single pill combination 5/20 mg
  • 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.
    Intervention: Drug: Amlodipine besylate
  • 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.
    Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
  • 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.
    Intervention: Drug: Amlodipine besylate
  • 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 .
    Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
April 2008
April 2008   (final data collection date for primary outcome measure)

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)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00412113
A3841045
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP