Official Title: “A 36 Week, Randomized, Double-Blind, Multi-Center, Parallel Group Study Comparing the Efficacy and Safety of Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension”

To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: Aliskiren/losartan
  • aliskiren 300 mg/losartan 100mg
• Drug: Aliskiren
  • Aliskiren 300 mg
• Drug: Losartan
  • Losartan 100 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Aliskiren 300 mg/losartan 100 mg
• Experimental: 2
  • aliskiren 300 mg
• Active Comparator: 3
  • losartan 100 mg

Primary Measures

• Change from baseline in left ventricular mass index using magnetic resonance imaging (MRI) for aliskiren 300 mg/losartan 100mg combination compared to losartan 100 mg
  • Time Frame: 36 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in LVMI as measured by MRI for aliskiren 300 mg compared to losartan 100 mg
  • Time Frame: 36 weeks
    Safety Issue?: No
• Change from baseline in LVH parameters as measured by MRI for aliskiren 300 mg/losartan 100 mg combination compared to each monotherapy
  • Time Frame: 36 weeks
    Safety Issue?: No
• Change in LVH parameters as measured by MRI for aliskiren 300 mg and losartan 100 mg monotherapies
  • Time Frame: 36 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients with essential hypertension
• Patients with a BMI > 25 kg/m2
• Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO

Exclusion Criteria:

• Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period.
• Patients treated with an ACE and ARB combination at study entry.
• Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).

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 Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219141

Study ID Number: CSPP100A2316

ClinicalTrials.gov Identifier: NCT00219141

Health Authority: United States: Food and Drug Administration