Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension (AACESS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00853957

First received: February 26, 2009

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Results First Received: December 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Aliskiren/Amlodipine Drug: Amlodipine

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
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Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Participant Flow: Overall Study

	Aliskiren/Amlodipine	Amlodipine
STARTED	220	223
COMPLETED	206	204
NOT COMPLETED	14	19
Adverse Event	9	3
Unsatisfactory therapeutic effect	0	2
Subject withdrew consent	4	5
Lost to Follow-up	1	6
Protocol deviation	0	3

Baseline Characteristics

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Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg
Total	Total of all reporting groups

Baseline Measures

	Aliskiren/Amlodipine	Amlodipine	Total
Number of Participants [units: participants]	220	223	443
Age [units: years] Mean ± Standard Deviation	53.2 ± 9.33	52.4 ± 10.57	52.8 ± 9.97
Age, Customized [units: participants]
<55 years	123	127	250
≥55 years	97	96	193
Gender [units: participants]
Female	123	115	238
Male	97	108	205

Outcome Measures

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1. Primary:

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, 8 weeks ]

Measure Type	Primary
Measure Title	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Measure Description	To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.
Time Frame	Baseline, 8 weeks
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, Last Observation Carried Forward (LOCF)

Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Measured Values

	Aliskiren/Amlodipine	Amlodipine
Number of Participants Analyzed [units: participants]	220	222
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [units: mm Hg] Mean ± Standard Deviation	-33.1 ± 14.53	-27.8 ± 13.45

No statistical analysis provided for Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

2. Secondary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, 8 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Measure Description	To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).
Time Frame	Baseline, 8 weeks
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, Last Observation Carried Forward (LOCF)

Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Measured Values

	Aliskiren/Amlodipine	Amlodipine
Number of Participants Analyzed [units: participants]	220	222
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [units: mm Hg] Mean ± Standard Deviation	-13.7 ± 9.60	-10.4 ± 9.08

No statistical analysis provided for Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

3. Secondary:

Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) [ Time Frame: 8 weeks ]

Measure Type	Secondary
Measure Title	Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
Measure Description	Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Time Frame	8 weeks
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

Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Measured Values

	Aliskiren/Amlodipine	Amlodipine
Number of Participants Analyzed [units: participants]	206	204
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) [units: Percentage of participants]	71.4	57.4

No statistical analysis provided for Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)

4. Secondary:

Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) [ Time Frame: 8 weeks ]

Measure Type	Secondary
Measure Title	Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
Measure Description	Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Time Frame	8 weeks
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

Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Measured Values

	Aliskiren/Amlodipine	Amlodipine
Number of Participants Analyzed [units: participants]	206	204
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) [units: Percentage of participants]	92.3	86.5

No statistical analysis provided for Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)

5. Secondary:

Change From Baseline in MSSBP at Week 1 and 4 [ Time Frame: Baseline, 1 and 4 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in MSSBP at Week 1 and 4
Measure Description	Compare the change from baseline in MSSBP at week 1 and 4
Time Frame	Baseline, 1 and 4 weeks
Safety Issue	Yes

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, Last Observation Carried Forward (LOCF)

Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Measured Values

	Aliskiren/Amlodipine	Amlodipine
Number of Participants Analyzed [units: participants]	215	219
Change From Baseline in MSSBP at Week 1 and 4 [units: mm Hg] Mean ± Standard Deviation
Baseline to Week 1	-20.5 ± 12.53	-18.2 ± 13.01
baseline to Week 4	-30.9 ± 13.30	-27.3 ± 13.58

No statistical analysis provided for Change From Baseline in MSSBP at Week 1 and 4

6. Secondary:

Percentage of Patients With Peripheral Edema by Visit [ Time Frame: 8 weeks ]

Measure Type	Secondary
Measure Title	Percentage of Patients With Peripheral Edema by Visit
Measure Description	Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.
Time Frame	8 weeks
Safety Issue	Yes

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

Reporting Groups

	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine 5mg titrated to 10 mg

Measured Values

	Aliskiren/Amlodipine	Amlodipine
Number of Participants Analyzed [units: participants]	220	223
Percentage of Patients With Peripheral Edema by Visit [units: Percentage of participants]
Week 1	1.4	1.3
Week 4	4.1	5.8
Week 8	6.8	8.5

No statistical analysis provided for Percentage of Patients With Peripheral Edema by Visit

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: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. Epub 2011 Sep 17.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00853957 History of Changes
Other Study ID Numbers:	CSPA100AUS01
Study First Received:	February 26, 2009
Results First Received:	December 6, 2010
Last Updated:	April 26, 2012
Health Authority:	United States: Food and Drug Administration

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