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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219141
First received: September 12, 2005
Last updated: May 20, 2011
Last verified: May 2011

September 12, 2005
May 20, 2011
October 2005
November 2007   (final data collection date for primary outcome measure)
Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
Not Provided
Complete list of historical versions of study NCT00219141 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as safety issue: No ]
    Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.
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Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Left Ventricular Hypertrophy
  • Overweight
  • 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
  • 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.
    Interventions:
    • Drug: Aliskiren 150/300 mg
    • Drug: Aliskiren placebo
    • Drug: Losartan 50/100 mg placebo
  • 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.
    Interventions:
    • Drug: Losartan 50/100 mg
    • Drug: Aliskiren placebo
  • 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.
    Interventions:
    • Drug: Aliskiren 150/300 mg
    • Drug: Losartan 50/100 mg
    • Drug: Aliskiren placebo
Pouleur AC, Uno H, Prescott MF, Desai A, Appelbaum E, Lukashevich V, Smith BA, Dahlöf B, Solomon SD; ALLAY Investigators. Suppression of aldosterone mediates regression of left ventricular hypertrophy in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2011 Dec;12(4):483-90. doi: 10.1177/1470320311414453. Epub 2011 Jul 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
November 2007
November 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Colombia,   Finland,   Germany,   Italy,   Russian Federation,   Spain,   Sweden
 
NCT00219141
CSPP100A2316
Not Provided
Novartis Pharmaceuticals, External Affairs
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP