Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome

This study has been completed.

Study NCT00409578 Information provided by Novartis

First Received on December 7, 2006. Last Updated on April 15, 2011 History of Changes

Results First Received: January 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Post Acute Coronary Syndrome Myocardial Ischemia
Interventions:	Drug: Placebo Drug: Aliskiren 300 mg Drug: Valsartan 320 mg Drug: Aliskiren/valsartan 300/320 mg

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
Placebo	Placebo tablets and capsules
Aliskiren 300 mg	Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Valsartan 320 mg	Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Aliskiren/Valsartan 300/320 mg	Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.

Participant Flow: Overall Study

	Placebo	Aliskiren 300 mg	Valsartan 320 mg	Aliskiren/Valsartan 300/320 mg
STARTED	280	271	269	281
COMPLETED	228	201	215	214
NOT COMPLETED	52	70	54	67
Adverse Event	27	37	25	33
Abnormal laboratory value(s)	2	2	2	4
Lack of Efficacy	0	0	0	2
Subject no longer requires study drug	0	0	0	1
Withdrawal by Subject	8	15	16	17
Lost to Follow-up	2	0	2	2
Administrative problems	8	9	2	4
Death	2	4	4	2
Protocol Violation	3	2	3	1
Missing	0	1	0	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo tablets and capsules
Aliskiren 300 mg	Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Valsartan 320 mg	Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Aliskiren/Valsartan 300/320 mg	Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.

Baseline Measures

	Placebo	Aliskiren 300 mg	Valsartan 320 mg	Aliskiren/Valsartan 300/320 mg	Total
Number of Participants [units: participants]	280	271	269	281	1101
Age [units: years] Mean ± Standard Deviation	63 ± 11.8	63 ± 11.7	64 ± 11.6	63 ± 11.1	63 ± 11.6
Gender [units: participants]
Female	103	86	72	87	348
Male	177	185	197	194	753

Outcome Measures

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1. Primary:

Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8 [ Time Frame: Baseline to Week 8 ]

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2. Secondary:

Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8 [ Time Frame: Baseline to Week 8 ]

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3. Secondary:

Percentage of Patients With a Cardiac Event [ Time Frame: Baseline to Week 8 ]

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4. Secondary:

Percentage of Patients With a Composite Clinical-biochemical Event [ Time Frame: Baseline to Week 8 ]

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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: 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

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00409578 History of Changes
Other Study ID Numbers:	CSPP100A2347
Study First Received:	December 7, 2006
Results First Received:	January 11, 2011
Last Updated:	April 15, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment