Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

This study has been completed.

Study NCT00529451 Information provided by Novartis

First Received on September 12, 2007. Last Updated on February 28, 2011 History of Changes

Results First Received: December 16, 2010

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

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 300 mg	Aliskiren 300 mg once daily
Aliskiren 150 mg	Aliskiren 150 mg once daily
Aliskiren 75 mg	Aliskiren 75 mg once daily
Ramipril 5 mg	Ramipril 5 mg once daily

Participant Flow: Overall Study

	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
STARTED	331	323	332	330
COMPLETED	294	275	292	299
NOT COMPLETED	37	48	40	31
Subject withdrew consent	16	21	13	12
Adverse Event	9	16	14	8
Unsatisfactory therapeutic response	6	2	5	4
Lost to Follow-up	4	7	4	4
Protocol deviation	1	1	4	1
Administrative problems	1	1	0	2

Baseline Characteristics

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Reporting Groups

	Description
Aliskiren 300 mg	Aliskiren 300 mg once daily
Aliskiren 150 mg	Aliskiren 150 mg once daily
Aliskiren 75 mg	Aliskiren 75 mg once daily
Ramipril 5 mg	Ramipril 5 mg once daily

Baseline Measures

	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg	Total
Number of Participants [units: participants]	331	323	332	330	1316
Age [units: years] Mean ± Standard Deviation	53.8 ± 9.45	53.3 ± 10.53	52.7 ± 10.22	52.9 ± 9.60	53.2 ± 9.95
Age, Customized [units: Participants]
< 65 years	288	273	285	296	1142
≥ 65 years	43	50	47	34	174
Gender [units: participants]
Female	150	140	144	151	585
Male	181	183	188	179	731

Outcome Measures

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1. Primary:

Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline and Week 8 ]

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2. Primary:

Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline and Week 8 ]

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3. Primary:

Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline and Week 8 ]

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4. Secondary:

Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint [ Time Frame: Baseline and Week 8 ]

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5. Secondary:

Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg [ Time Frame: Week 8 ]

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6. Secondary:

Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP [ Time Frame: 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:	NCT00529451 History of Changes
Other Study ID Numbers:	CSPP100A2339
Study First Received:	September 12, 2007
Results First Received:	December 16, 2010
Last Updated:	February 28, 2011
Health Authority:	China: State Food and Drug Administration; United States: Food and Drug Administration