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.

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren; Drug: Valsartan; Drug: Hydrochlorothiazide (HCTZ)

• Registration Number: NCT00386607
• Lead Sponsor: Novartis

Brief Summary

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2010-12-20
• Results First Submitted QC: 2011-04-07
• Results First Posted: 2011-05-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

• Male and female outpatients 18 years of age and older.
• For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
• For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
• Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).

Exclusion Criteria

• Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
• Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
• History or evidence of a secondary form of hypertension.
• History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extension Treatment	Hydrochlorothiazide (HCTZ)	For patients entering into extension, those previously treated with Hydrochlorothiazide (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 mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.
Core Treatment	Aliskiren	Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Core Treatment	Valsartan	Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Extension Treatment	Aliskiren	For patients entering into extension, those previously treated with Hydrochlorothiazide (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 mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.
Extension Treatment	Valsartan	For patients entering into extension, those previously treated with Hydrochlorothiazide (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 mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.

Primary Outcome Measures

Name	Time	Method
Overall Percentage of Patients With Adverse Events	Month 18	adverse event data obtained from both the core study and the 6 month extension study.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure.	Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Diastolic Blood Pressure	Baseline and Month 18
Change From Baseline in Mean Sitting Systolic Blood Pressure.	Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Change From Baseline in Mean Sitting Systolic Blood Pressure	Baseline and Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment	Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg	.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54

Trial Locations

Locations (1)

Investigative Centers; 🇳🇱 Netherlands, Netherlands