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.

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ClinicalTrials.gov Identifier: NCT00386607

Recruitment Status : Completed

First Posted : October 11, 2006

Results First Posted : May 10, 2011

Last Update Posted : February 10, 2014

Sponsor:

Information provided by:

Novartis

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Hypertension
Interventions	Drug: Aliskiren Drug: Valsartan Drug: Hydrochlorothiazide (HCTZ)
Enrollment	601

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Core Treatment	Extension Treatment
Arm/Group Description	Oral pills of aliskiren 150 mg /val...	For patients entering into extensio...
Arm/Group Description	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.	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.
Period Title: Core
Started	601	0
Completed	486	0
Not Completed	115	0
Reason Not Completed
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 Title: Extension
Started	0	162
Completed	0	145
Not Completed	0	17
Reason Not Completed
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

Arm/Group Title		Core Treatment
Arm/Group Description		Oral pills of aliskiren 150 mg /val...
Arm/Group Description		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.
Overall Number of Baseline Participants		601
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	601 participants
		55.0 (11.20)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	601 participants
	Female	271 45.1%
	Male	330 54.9%

Outcome Measures

1.Primary Outcome


Title	Overall Percentage of Patients With Adverse Events
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Month 12

Outcome Measure Data