Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension

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.

Intervention(s) in this Clinical Trial

• Drug: Aliskiren 150/300 mg
  • Aliskiren 150 mg tablets
• Drug: Losartan 50/100 mg
  • Losartan 50 or 100 mg capsules
• Drug: Aliskiren placebo
  • Aliskiren 150 mg placebo tablet
• Drug: Losartan 50/100 mg placebo
  • Losartan 50/100 mg placebo capsules

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Aliskiren 300 mg
  • Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.
• Active Comparator: Losartan 100 mg
  • Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.
• Experimental: Aliskiren/losartan 300/100 mg
  • Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.

Primary Measures

• Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No

Secondary Measures

• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)
  • Time Frame: Baseline to end of study (Week 36)
    Safety Issue?: No
• Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)
  • Time Frame: Baseline the end of study (Week 36)
    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).
• Other protocol related inclusion/exclusion criteria applied to the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals 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/NCT00219141

Study ID Number: CSPP100A2316

ClinicalTrials.gov Identifier: NCT00219141

Health Authority: United States: Food and Drug Administration