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.

Official Title: “A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)”

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).

Intervention(s) in this Clinical Trial

• Drug: Aliskiren
  • Aliskiren 300 mg
• Drug: Valsartan
  • Valsartan 320 mg
• Drug: Hydrochlorothiazide (HCTZ)
  • Hydrochlorothiazide (HCTZ) 12.5-25 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Core Treatment
  • 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.
• Experimental: Extension Treatment
  • 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 Measures

• Overall Percentage of Patients With Adverse Events
  • Time Frame: Month 12
    Safety Issue?: Yes
• Overall Percentage of Patients With Adverse Events
  • Time Frame: Month 18
    Safety Issue?: Yes

Secondary Measures

• Change From Baseline in Mean Sitting Diastolic Blood Pressure.
  • Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
    Safety Issue?: No
• Change From Baseline in Mean Sitting Systolic Blood Pressure.
  • Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline in Mean Sitting Diastolic Blood Pressure
  • Time Frame: Baseline and Month 18
    Safety Issue?: No
• Change From Baseline in Mean Sitting Systolic Blood Pressure
  • Time Frame: Baseline and Month 18
    Safety Issue?: No
• Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
  • Time Frame: Month 18
    Safety Issue?: No

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386607

Study ID Number: CSPV100A2301

ClinicalTrials.gov Identifier: NCT00386607

Health Authority: United States: Food and Drug Administration