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

History of Changes

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
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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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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

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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 ]

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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Measure Type	Secondary
Measure Title	Subjects With BP < 140/90 mmHg at Week 6
Measure Description	Subjects achieving BP goal of <140/90 mmHg at week 6
Time Frame	Week 6
Safety Issue	No

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.
Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.

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.

Measured Values

	Norvasc + TLC	Caduet + TLC
Number of Participants Analyzed [units: participants]	115	118
Subjects With BP < 140/90 mmHg at Week 6 [units: participants]	83	94

Statistical Analysis 1 for Subjects With BP < 140/90 mmHg at Week 6

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.171
Odds Ratio (OR) ^[4]	1.55
95% Confidence Interval	( 0.83 to 2.88 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (< 140/90 mmHg) at Week 6.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustment for p-value for secondary analyses
[4]	Other relevant estimation information:
	No text entered.

10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Limitations and Caveats

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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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

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