A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

This study has been completed.

Study NCT00386607 Information provided by Novartis

First Received on October 10, 2006. Last Updated on April 7, 2011 History of Changes

Results First Received: December 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Aliskiren Drug: Valsartan Drug: Hydrochlorothiazide (HCTZ)

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

Core Treatment

Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.

Extension Treatment

For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.

Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.

The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits.

Participant Flow for 2 periods

Period 1: Core

	Core Treatment	Extension Treatment
STARTED	601	0
COMPLETED	486	0
NOT COMPLETED	115	0
Adverse Event	40	0
Abnormal laboratory value(s)	3	0
Unsatisfactory therapeutic effect	23	0
Condition no longer requires study drug	4	0
Patient withdrew consent	15	0
Lost to Follow-up	23	0
Administrative problems	1	0
Protocol Deviation	6	0

Period 2: Extension

	Core Treatment	Extension Treatment
STARTED	0	162
COMPLETED	0	145
NOT COMPLETED	0	17
Adverse Event	0	6
Abnormal laboratory value(s)	0	1
Administrative problems	0	1
Lost to Follow-up	0	3
Patient withdrew consent	0	5
Unsatisfactory therapeutic effect	0	1

Baseline Characteristics

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Reporting Groups

	Description
Core Treatment	Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.

Baseline Measures

	Core Treatment
Number of Participants [units: participants]	601
Age [units: years] Mean ± Standard Deviation	55.0 ± 11.20
Gender [units: participants]
Female	271
Male	330

Outcome Measures

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1. Primary:

Overall Percentage of Patients With Adverse Events [ Time Frame: Month 12 ]

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2. Primary:

Overall Percentage of Patients With Adverse Events [ Time Frame: Month 18 ]

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3. Secondary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]

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4. Secondary:

Change From Baseline in Mean Sitting Systolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54 ]

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5. Secondary:

Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg [ Time Frame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]

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6. Secondary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline and Month 18 ]

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7. Secondary:

Change From Baseline in Mean Sitting Systolic Blood Pressure [ Time Frame: Baseline and Month 18 ]

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8. Secondary:

Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment [ Time Frame: Month 18 ]

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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
Open label study with no comparator treatment/arm.

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:

Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. Epub 2010 Nov 9.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00386607 History of Changes
Other Study ID Numbers:	CSPV100A2301
Study First Received:	October 10, 2006
Results First Received:	December 20, 2010
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices