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
Results First Received: April 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Dyslipidemia
Hypertension
Interventions: Drug: Amlodipine besylate
Drug: Amlodipine besylate/atorvastatin calcium single pill combination

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study enrolled 244 evaluable subjects. Drug treatments were used prior to the start of the study in all subjects in the Caduet and therapeutic lifestyle changes (TLC) group and the Norvasc and TLC group. Amlodipine was used by all subjects prior to entry. The study's four arms are two groups, each with drug group and matching placebo.

Reporting Groups
  Description
Norvasc + TLC Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
Caduet + TLC Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.

Participant Flow:   Overall Study
    Norvasc + TLC     Caduet + TLC  
STARTED     123 [1]   122 [1]
Received Treatment     122 [2]   122  
COMPLETED     111 [3]   107 [3]
NOT COMPLETED     12     15  
Adverse Event                 11                 15  
did not receive treatment                 1                 0  
[1] 15-January-2007
[2] One subject assigned to Norvasc and TLC did not receive treatment and was excluded from all analyses
[3] 15-April-2008



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Norvasc + TLC Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
Caduet + TLC Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    Norvasc + TLC     Caduet + TLC     Total  
Number of Participants  
[units: participants]
  122     122     244  
Age, Customized  
[units: participants]
     
18 to 64 years     95     97     192  
> or = to 65 years     27     25     52  
Gender  
[units: participants]
     
Female     56     65     121  
Male     66     57     123  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk   [ Time Frame: Week 6, baseline ]

3.  Secondary:   Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4   [ Time Frame: Week 4 ]

4.  Secondary:   Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.   [ Time Frame: Week 4 ]

5.  Secondary:   Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.   [ Time Frame: Week 6 ]

6.  Secondary:   Subjects With LDL-C < 100 mg/dL at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Subjects With LDL-C < 100 mg/dL at Week 6   [ Time Frame: Week 6 ]

8.  Secondary:   Subjects With BP < 140/90 mmHg at Week 4   [ Time Frame: Week 4 ]

9.  Secondary:   Subjects With BP < 140/90 mmHg at Week 6   [ Time Frame: Week 6 ]

10.  Secondary:   Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).   [ Time Frame: Week 4, baseline ]

11.  Secondary:   Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)   [ Time Frame: Week 4, baseline ]

12.  Secondary:   Change From Baseline to Week 4 in Pulse Rate   [ Time Frame: Week 4, baseline ]

13.  Secondary:   Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)   [ Time Frame: Week 6, baseline ]

14.  Secondary:   Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)   [ Time Frame: Week 6, baseline ]

15.  Secondary:   Change From Baseline to Week 6 in Pulse Rate   [ Time Frame: Week 6, baseline ]

16.  Secondary:   Change From Baseline in LDL at Week 4.   [ Time Frame: Week 4, baseline ]

17.  Secondary:   Change From Baseline in High Density Lipoprotein (HDL) at Week 4.   [ Time Frame: Week 4, baseline ]

18.  Secondary:   Change in Total Cholesterol (TC) From Baseline to Week 4.   [ Time Frame: Week 4, baseline ]

19.  Secondary:   Change From Baseline in Triglycerides (TG) to Week 4.   [ Time Frame: Week 4, baseline ]

20.  Secondary:   Change From Baseline in LDL at Week 6.   [ Time Frame: Week 6, baseline ]

21.  Secondary:   Change From Baseline in HDL at Week 6.   [ Time Frame: Week 6, baseline ]

22.  Secondary:   Change From Baseline in Total Cholesterol (TC) to Week 6.   [ Time Frame: Week 6, baseline ]

23.  Secondary:   Change From Baseline in Triglycerides (TG) at Week 6.   [ Time Frame: Week 6 , baseline ]

24.  Secondary:   Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.   [ Time Frame: Week 4, baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


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